MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE SPARTACORE GUIDE WIRE

Catalog Number	1005203
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.The investigation determined that the reported difficulties and foreign body in patient appear to be due to case circumstances.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the electronic complaint handling database revealed no other similar incidents reported from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a chronic total occlusion in the mid superficial femoral artery with heavy calcification and mild tortuosity.A high torque (ht) spartacore guide wire was advanced toward the target lesion.A non-abbott re-entry catheter was advanced over the guide wire.When the re-entry catheter was pulled resistance was noted and the needle on the device broke the guide wire tip off which remained in subintimal space.No attempt was made to retrieve the separated tip.Everything was pulled out and a new all star guide wire was advanced toward the target lesion.A new re-entry catheter was successfully advanced over the guide wire to treat the lesion.The lesion was ultimately treated with two supera stents.There was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: HI-TORQUE SPARTACORE GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 5855302
• Report Number: 2024168-2016-05247
• Device Sequence Number: 841617
• Product Code: DQX
• UDI-Device Identifier: 08717648014031
• UDI-Public: (01)08717648014031(17)180228(10)6032361
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K980119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 1005203
• Device Lot Number: 6032361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2016
• Initial Report FDA Received Date: 08/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Weight: 90