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

Catalog Number	1005351H
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2016
Type of Reportable Event	Malfunction
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 analysis.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 reported from this lot.The investigation determined the reported difficulties appear to be related to calcification in the patient anatomy.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 during a procedure of the heavily tortuous, moderately calcified, 80% stenosed, eccentric, de novo, distal left anterior descending (lad) artery a non-abbott guide wire was placed and a ht whisper guide wire was advanced to a side branch and met anatomical resistance and failed to cross.The whisper guide wire was removed and outside the anatomy the tip was floppy and had loss shape.A different device was used in the procedure and a xience stent was implanted without issue.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.

• Brand Name: HI-TORQUE WHISPER LS 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: 6118539
• Report Number: 2024168-2016-08196
• Device Sequence Number: 16412786
• Product Code: DQX
• UDI-Device Identifier: 08717648037740
• UDI-Public: (01)08717648037740(17)171130(10)5121471
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 1005351H
• Device Lot Number: 5121471
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2016
• Initial Report FDA Received Date: 11/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE: RUNTHROUGH