MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

Model Number	1009666
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record could not be conducted as the lot number was not provided.Additionally, a review of the complaint history was not conducted because the lot number was not provided.The investigation was unable to determine a conclusive cause for the reported difficulty.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 nc trek device will be filed under another medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat an unspecified lesion.The balance middle weight guide wire (bmw gw) was advanced to the lesion.Then the 3.0x15mm nc trek balloon was attempted to be advanced but met resistance with the gw.It was then attempted to remove the balloon but could not remove from the guide wire, therefore while attempting to remove both, the balloon broke.Resistance was met with both devices during removal.Another device was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and dimensional inspections were performed on the returned device.The reported difficulty to advance/position and difficulty to remove were unable to be confirmed due to the returned condition of the device.A review of the lot history record could not be conducted as the lot number was not provided.Additionally, a review of the complaint history was not conducted due to no lot number being provided.The investigation determined the reported difficulties and noted damages appear to be related to operation circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.D10, h3: device status changed from not returned to returned.Method code 4115 was removed.Conclusion code 67 was removed.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9938093
• Report Number: 2024168-2020-03494
• Device Sequence Number: 2718251
• Product Code: DQX
• UDI-Device Identifier: 08717648118739
• UDI-Public: 08717648118739
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K072460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2020

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 Model Number: 1009666
• Device Catalogue Number: 1009666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 05/04/2020
• 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: NC TREK BALLOON