MAUDE Adverse Event Report: AV-TEMECULA-CT 014 HT WINN GUIDE WIRE

Catalog Number	1012467
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents reported from this lot.The investigation determined the reported difficulties to be related to the patient anatomical conditions.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 heavily calcified lesion in the superficial femoral artery (sfa).A ht winn guide wire was advanced retrograde through the anterior tibialis; however, the guide wire could not cross and the tip became separated due to the heavy calcification.The tip was not retrieved.It was stated that the physician felt comfortable leaving the tip in as it was in a subintimal plane of the vessel in the sfa and there was no blood flow reaching the segment to injure the patient.Additionally, the procedure was unsuccessful and the patient will be counseled on having bypass surgery.There was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: 014 HT WINN 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: 6329964
• Report Number: 2024168-2017-01177
• Device Sequence Number: 11004972
• Product Code: DQX
• UDI-Device Identifier: 08717648156823
• UDI-Public: (01)08717648156823(17)180228(10)6032171
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091825
• 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): 02/14/2017

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: 1012467
• Device Lot Number: 6032171
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2017
• Initial Report FDA Received Date: 02/14/2017
• 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: 84 YR
• Patient Weight: 102