MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

Catalog Number	1009661
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Evaluation summary: visual and dimensional inspections were performed on the returned device.The reported guide wire separation was confirmed although difficult to position and remove could not be replicated in a testing environment as the reported device was returned separated.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.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.The investigation was unable to determine a conclusive cause for the reported difficulties.
Event or Problem Description
It was reported that the procedure was to treat a lesion located below the knee.The vessel had moderate tortuosity and heavy calcification.After successfully placing the balance middleweight universal guide wire, a 2.0 trek balloon was advanced over the guide wire; however, resistance was felt and it stopped advancing.As the balloon catheter and the guide wire were stuck together, they were removed together from the anatomy, at which time it was observed that the guide wire had separated leaving about 12 inches of the distal end in the anatomy.A snare device was used to capture and retrieve the separated segment of guide wire successfully.A new guide wire was advanced for completion of the procedure.The same 2.0 trek balloon was advanced over the guide wire, this time without issue.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL 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: 5866667
• Report Number: 2024168-2016-05300
• Device Sequence Number: 16256888
• Product Code: DQX
• UDI-Device Identifier: 08717648014345
• UDI-Public: (01)08717648014345(17)180228(10)6030171
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K013833
• 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): 08/10/2016

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: 02/28/2018
• Device Catalogue Number: 1009661
• Device Lot Number: 6030171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2016
• Initial Report FDA Received Date: 08/10/2016
• 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