MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	A1030-060
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.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 and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty advancing and removing the device from the guide wire.Factors that may contribute to the difficult advancing and removing the balloon dilatation catheter (bdc) from the guide wire causing resistance between the devices may include, but not limited to, manufacturing damage, device placement technique, guiding catheter support, inner diameter of guide wire lumen, condition of the guide wire, or damage to the distal shaft of the catheter.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.The additional ht command device referenced in b5 is filed under separate medwatch report number.Na.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified tibial artery that is 90% stenosed.The 014 ht command guide wire crossed lesion successfully.The 3.0x60mm armada 14 balloon dilatation catheter was advanced and used to pre-dilate the lesion successfully even though resistance was met during advancement with the guide wire.Once removed the 4.0x38mm xience prime stent delivery system was attempted to advance over the wire; however, resistance was met with the guide wire.The same armada 14 balloon was attempted to be advanced over the guide wire, but met resistance was noted again.The balloon and guide wire were removed together.The guide wire was removed and the coating was noted to be peeled but remaining on the guide wire.Another command guide wire and xience prime were used to successfully complete the procedure.There were no clinically significant delay reported.No additional information was provided.

• Brand Name: ARMADA 14 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 15571248
• Report Number: 2024168-2022-10458
• Device Sequence Number: 2906418
• Product Code: DQY
• UDI-Device Identifier: 08717648155802
• UDI-Public: 08717648155802
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/10/2022

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: 01/31/2025
• Device Model Number: A1030-060
• Device Catalogue Number: A1030-060
• Device Lot Number: 1083141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 10/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 014 HT COMMAND GUIDE WIRE
• Patient Sex: Unknown