MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE WHISPER MS GUIDE WIRE; GUIDE WIRES

Catalog Number	1005359HJ
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2017
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.Evaluation summary: the device was returned for analysis.Visual and dimensional inspections were performed on the returned device.The separation was confirmed.The physical resistance could not be replicated in a testing environment as it was based on operational circumstances.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 similar incidents from this lot.The investigation determined the reported physical resistance and separation appear to be related to the anatomical condition.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that a balloon dilatation catheter (bdc) was being advanced on the whisper guide wire and met resistance with the anatomy when the doctor could no longer feel the guide wire movement distally.The bdc was removed with the guide wire when it was noticed that the distal tip of the guide wire had separated in the anterior tibial artery.A non-abbott filter was inserted to remove the separated tip from the tibial artery.There was no reported adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: HI-TORQUE WHISPER MS GUIDE WIRE
• Common Device Name: GUIDE WIRES
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6364469
• Report Number: 2024168-2017-01613
• Device Sequence Number: 744533
• Product Code: DQX
• UDI-Device Identifier: 08717648037832
• UDI-Public: (01)08717648037832(17)180831(10)6092071
• Combination Product (Y/N): N
• PMA/510(K) Number: K101116
• 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): 02/28/2017

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: 08/31/2018
• Device Catalogue Number: 1005359HJ
• Device Lot Number: 6092071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2017
• Initial Report FDA Received Date: 02/28/2017
• 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: Required Intervention