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

Catalog Number	1011835H
Health Effect - Clinical Code	Perforation (2001)
Date of Event	10/25/2016
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 analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.Based on the case information, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.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 heavily calcified lesions with mild tortuosity in the circumflex (cx) and the left anterior descending (lad) artery.A whisper guide wire was advanced toward the target lesion.Rotoblating was performed in the cx.An unspecified balloon was used to predilate the lesion.A 4x28mm xience alpine stent was advanced toward the lesion and successfully deployed.Rotoblating was performed in the lad.An unspecified balloon was used to predilate the lesion.A 3x23mm xience alpine was advanced toward the lesion and successfully deployed.Near the end of the procedure a very distal perforation was noted.The perforation was not located near the alpine stents.The perforation healed itself so no additional medical intervention was performed.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

• 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: 6077790
• Report Number: 2024168-2016-07573
• Device Sequence Number: 16330693
• Product Code: DQX
• UDI-Device Identifier: 08717648116117
• UDI-Public: (01)08717648116117
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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): 11/03/2016

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1011835H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2016
• Initial Report FDA Received Date: 11/03/2016
• 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: STENT: 4X28MM XIENCE ALPINE, 3X23MM ALPINE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR