MAUDE Adverse Event Report: AV-TEMECULA-CT ACS HI-TORQUE EXTRA SPORT GUIDE WIRE WITH MICROGLIDE COATING

Catalog Number	22235M
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2016
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 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 reported from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the tip of the guide wire became stuck with the deployed stent, such that any attempt to retract the device in this entrapped state would have resulted in tensile or torsional loads beyond its design limits causing the guide wire to detach.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 lesion in the right coronary artery.A 014 s'port guide wire was inserted into the lesion and a 2.25x18mm xience alpine stent was implanted proximally.The guide wire was pulled back and a 2.25x23mm xience alpine stent delivery system (sds) was advanced.An attempt to advance the 2.25x23mm xience alpine stent distally was made; however, it could not cross past the 2.25x18mm xience alpine stent.The 2.25x23mm xience alpine sds was removed; however, the guide wire became stuck in the stent.The guide wire separated and a micro snare gooseneck retrieval wire was used to remove the distal tip of the guide wire.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

• Brand Name: ACS HI-TORQUE EXTRA SPORT GUIDE WIRE WITH MICROGLIDE COATING
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6220412
• Report Number: 2024168-2017-00045
• Device Sequence Number: 52760
• Product Code: DQX
• UDI-Device Identifier: 08717648079603
• UDI-Public: (01)08717648079603(17)180331(10)6040761
• 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): 01/03/2017

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: 03/31/2018
• Device Catalogue Number: 22235M
• Device Lot Number: 6040761
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2016
• Initial Report FDA Received Date: 01/03/2017
• 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: XIENCE ALPINE (X2)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 98