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

Catalog Number	22299MS
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 was unable to determine a conclusive cause for the separation.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 a mildly tortuous obtuse marginal (om) artery.A ht floppy es guide wire was used during a procedure where an intervention was successfully performed.At the end of the procedure when the devices were removed from the anatomy, it was noted that the tip of the guide wire had separated and remained in the om.There was no reported resistance advancing or removing the guide wire.Attempts were made to remove the tip with a snare device but it could not be removed and remains in the om.The procedure was completed at this time without additional treatment.There was a clinically significant delay in the procedure due to the attempts to remove the tip.No additional information was provided.

• Brand Name: ACS HI-TORQUE FLOPPY II 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: 6035322
• Report Number: 2024168-2016-07024
• Device Sequence Number: 902804
• Product Code: DQX
• UDI-Device Identifier: 08717648079696
• UDI-Public: (01)08717648079696(17)180731(10)6082261
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 10/17/2016

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 22299MS
• Device Lot Number: 6082261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2016
• Initial Report FDA Received Date: 10/17/2016
• 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: Required Intervention