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

Catalog Number	1011834HJ
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/16/2018
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 returned for analysis with the polymer separated.The reported difficult to position was unable to be replicated in a testing environment due to the condition of the returned device.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 from this lot.As there was no damage noted to the guide wire during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure.Manipulation of the devices resulted in the noted guide wire separated/bunched polymer coating and the noted sds wrinkled inner/outer member and the noted wrinkled balloon shoulders; thus ultimately resulting in the reported difficulty to position.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to be performed with a 2.25 x 15 mm xience xpedition stent delivery system (sds) and a 014 whisper support guide wire.The sds was advancing over the guide wire, but could not cross the target lesion.Reportedly, the sds failed to position due to probable lumen obstruction.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.No additional information was provided.Analysis of the whisper guide wire revealed the polymer coating was separated and bunched.Additionally, in the guide wire lumen of the xience xpedition sds there was a black substance present sporadically that appeared to be multiple separated pieces of polymer coating.

• Brand Name: HI-TORQUE WHISPER ES 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: 8075900
• Report Number: 2024168-2018-08838
• Device Sequence Number: 13514078
• Product Code: DQX
• UDI-Device Identifier: 08717648116094
• UDI-Public: 08717648116094
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K101116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2018

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: 10/31/2019
• Device Catalogue Number: 1011834HJ
• Device Lot Number: 7112271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 11/15/2018
• 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: 83 YR