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Adverse Event Report

ACS/DVI ACS HI-TORQUE FLOPPY 11 EXTRA SUPPORT GUIDE WIRE   back to search results
Catalog Number 22359M-901
Event Date 06/06/1997
Event Type  Injury   Patient Outcome  Life Threatening; Required Intervention
Event Description

It was reported that during a ptca of a tortuous mid ramus artery, the tip of the guide wire separated and remained in the distal portion of the vessel;. Attempts to retrieve the wire fragment were unsuccessful. Ultimately, a perforation occurred, resulting in a pericardial tamponade. The pt was taken to surgery where a pericardial window procedure was performed. Following this the pt returned to the cardiac cath lab, where further retrieval attempts were undertaken. This proved to be unsuccessful. The pt returned to the operating room for open heart surgery. During surgery the wire fragment was removed and the perforation was repaired. Reportedly, the pt developed complications postoperatively and was in guarded condition. The product has been retained by the user facility.

 
Manufacturer Narrative

During processing of this complaint qa attempted to obtain complete info of the event and pt status from the hosp, field contact or distributor.

 
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Brand NameACS HI-TORQUE FLOPPY 11 EXTRA SUPPORT GUIDE WIRE
Type of DeviceGUIDE WIRE
Baseline Brand NameHI-TORQUE FLOPPY II GUIDE WIRE
Baseline Catalogue NumberNA
Baseline Model Number22359M-901
Other Baseline ID NumberPRODUCT LINE=GUIDE WIRES
Baseline Device FamilyGUIDE WIRES
Baseline Device 510(K) NumberK913353
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Manufacturer (Section F)
ACS/DVI
26531 ynez rd.
temecula CA 92591
Manufacturer (Section D)
ACS/DVI
26531 ynez rd.
temecula CA 92591
Manufacturer (Section G)
ABBOTT VASCULAR-CARDIAC THERAPIES
26531 ynez rd.
mailing p.o. box 9018
temecula CA 92589 9018
Manufacturer Contact
eileen tucker-casal
26531 ynez rd
temecula , CA 92591-4628
(909) 914 -2050
Device Event Key105174
MDR Report Key107010
Event Key97292
Report Number2024168-1997-00097
Device Sequence Number1
Product CodeDQX
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 06/06/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/03/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number22359M-901
OTHER Device ID Number420565-001
Was Device Available For Evaluation? Device Returned To Manufacturer
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Ageunknown
Event Location Hospital
Date Manufacturer Received06/06/1997
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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