MAUDE Adverse Event Report: ABBOTT VASCULAR HT COMMAND 14; GUIDE WIRE

Model Number	2078174
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	07/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The additional rx viatrac plus device referenced in b5 and d11 is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a renal artery.A 5x20mm viatrac plus balloon was placed over a hi-torque command guide wire, and resistance was met when advancing the balloon over the wire.Therefore, it was decided to remove the balloon, but force had to be applied as resistance was met, and the balloon portion separated.The devices were simply removed altogether and it was confirmed that nothing remained in the anatomy.Another balloon and guide wire were 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
The device was returned for analysis.The reported difficulties to remove and advance were not confirmed due to device condition.The noted kink was likely due to case circumstances.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 similar incidents reported from this lot.The investigation determined the reported difficulty to advance and remove the guide wire through the balloon catheter appears to be related to operational circumstances of the procedure.Based on the reported information, it is likely that the shaft of the viatrac plus became damaged during advancement through the anatomy and/or other devices used resulting in the difficulty to advance/ remove.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 renal artery.A 5x20mm viatrac plus balloon was placed over a hi-torque command guide wire, and resistance was met when advancing the balloon over the wire.Therefore, it was decided to remove the balloon, but force had to be applied as resistance was met, and the balloon portion separated.The devices were simply removed altogether and it was confirmed that nothing remained in the anatomy.Another balloon and guide wire were 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.Subsequent to filing the initial report, the following additional information was received from the account confirming that the shaft separated, not the balloon portion as initially reported.No additional information was provided.

• Brand Name: HT COMMAND 14
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10337834
• Report Number: 2024168-2020-06275
• Device Sequence Number: 14223968
• Product Code: DQX
• UDI-Device Identifier: 08717648176678
• UDI-Public: 08717648176678
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2020

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 Expiration Date: 06/30/2021
• Device Model Number: 2078174
• Device Catalogue Number: 2078174
• Device Lot Number: 9071671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 10/09/2020
• 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: 5X20MM VIATRAC PLUS BALLOON; 5X20MM VIATRAC PLUS BALLOON