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Adverse Event Report

3M HEALTH CARE/ SARNS AND CDI PRODUCTS SARNS HIGH FLOW AORTIC ARCH CANNULA ARTERIAL CANNULA   back to search results
Model Number 98-0702-0045-0
Event Date 12/30/1997
Event Type  Malfunction   Patient Outcome  Required Intervention;
Event Description

After insertion of the cannula into the pt's aorta, it was discovered that the tip of the cannula was misaligned by 180 degrees with respect to the reference line on the cannula tubing. Upon this discovery, the surgeon rotated the cannula such that the tip was facing in the proper direction with respect to the pt's aorta. No pt injury has been reported as a result of this incident.

 
Manufacturer Narrative

In addition, the submission of the medical device report is required of device mfrs by 21 cfr 803. Neither the submission of info by a mfr pursuant to this rule nor public release of such info, constitutes an admission that a device has malfunctioned or establishes the existence of any connection between a product and any death or injury. The info in the medical device report is based primarily on info related by third party sources; the accuracy of their reports and veracity of the sources have not been confirmed by the reporting party. Any business info contained in this report, such as sales and production figures, are confidential info and should be treated as such.

 
Search Alerts/Recalls

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Brand NameSARNS HIGH FLOW AORTIC ARCH CANNULA
Type of DeviceARTERIAL CANNULA
Baseline Brand NameHIGH FLOW CANNULA, SUTURE FLANGE, 6.5 MM
Baseline Generic NameARTERIAL CANNULA
Baseline Catalogue Number12325
Baseline Model Number98-0702-0045-0
Baseline Device FamilyAORTIC ARCH CANNULA PRODUCTS
Baseline Device 510(K) Number
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? Yes
Transitional? No
510(K) Exempt? No
Shelf Life(Months)36
Date First Marketed01/01/1971
Manufacturer (Section F)
3M HEALTH CARE/ SARNS AND CDI PRODUCTS
6200 jackson rd.
ann arbor MI 48103
Manufacturer (Section D)
3M HEALTH CARE/ SARNS AND CDI PRODUCTS
6200 jackson rd.
ann arbor MI 48103
Manufacturer (Section G)
TERUMO CARDIOVASCULAR SYSTEMS CORP.
6200 jackson rd.
ann arbor MI 48103
Manufacturer Contact
steven arick
6200 jackson rd
ann arbor , MI 48103
(734) 663 -4145
Device Event Key145446
MDR Report Key149253
Event Key140118
Report Number1828100-1998-00004
Device Sequence Number1
Product CodeDWF
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 02/13/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/13/1998
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date08/01/2000
Device MODEL Number98-0702-0045-0
Device Catalogue Number12325
Device LOT NumberA081897
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer01/15/1998
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/15/1998
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/1997
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on February 28, 2009

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