MAUDE Adverse Event Report: AV-TEMECULA-CT ACS HI-TORQUE WIGGLE GUIDE WIRE

Catalog Number	22399M-W30
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2017
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 xience alpine referenced is being filed under separate medwatch report.Evaluation summary: the device was returned for analysis.Visual, dimensional, and functional inspections were performed on the returned device.The difficulty removing the sds was confirmed.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.The investigation determined the difficulties to be related to circumstances of the procedure.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 chronic total occluded lesion in the circumflex artery.A 2.5x15mm xience rx stent was implanted in the mid left anterior descending artery; however, it was decided that another stent was needed distally due to the low blood flow.A 2.5x23mm xience alpine rx stent was deployed at 12 atmospheres distally; however, the delivery system was pulled back a little bit to balloon the area where both stents over-lapped when the balloon ruptured.Resistance with the guide wire was felt when removing the delivery system.Both the delivery system and guide wire were removed together.It was further reported that the 2.5x23mm xience alpine delivery system was not prepped prior to use.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.Additional information: the return device analysis revealed that the xience alpine stent delivery system was returned frozen on an abbott.014 wiggle guide wire.

• Brand Name: ACS HI-TORQUE WIGGLE 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: 6516653
• Report Number: 2024168-2017-03533
• Device Sequence Number: 14190
• Product Code: DQX
• UDI-Device Identifier: 08717648080487
• UDI-Public: (01)08717648080487
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K060449
• 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): 04/24/2017

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 Catalogue Number: 22399M-W30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2017
• Initial Report FDA Received Date: 04/24/2017
• 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: 2.5X23MM XIENCE ALPINE, 2.5X15MM XIENCE
• Patient Age: 62 YR
• Patient Weight: 120