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

Model Number	A2020-080
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified, mildly tortuous, 60% stenosed lesion in the anterior tibial artery.It was observed that the coating of an ht command es guide wire (gw) was discolored for approximately 2 to 3cm.It also felt rougher compared to the rest of the hydrophilic coating.The gw was advanced to the lesion without issue; however, the hydrophilic coating was peeling off very quickly and sheared off when loading an armada 14 balloon onto the guide wire.Resistance was noticed during removal of the gw from the anatomy and with removal of the armada bdc from the gw as well.There was no adverse patient effect and no clinically significant delay in the procedure.A non-abbott device was used to successfully complete the procedure.No additional information was provided.
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 removing the device from the guide wire.However, factors that may contribute to resistance with the guide wire may include, but are not limited to, device placement technique, introducer sheath support, inner diameter of guide wire lumen, outer diameter of the guide wire, condition of the guide wire, or damage to the distal shaft of the catheter.Additionally, other factors may also consist of anatomical conditions, such as tortuous vessels, as they could cause the shape of the guide wire or catheter to become angled and make it more difficult to advance the catheter over the wire.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.The guide wire referenced is filed under mfr # 2024168-2022-04833-00.

• 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: 14575115
• Report Number: 2024168-2022-05897
• Device Sequence Number: 17670552
• Product Code: DQY
• UDI-Device Identifier: 08717648155970
• UDI-Public: 08717648155970
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2022

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: 03/31/2025
• Device Model Number: A2020-080
• Device Catalogue Number: A2020-080
• Device Lot Number: 1102341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2021
• 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: ARMADA 14 BALLOON; ASAHI GLADIUS
• Patient Sex: Unknown