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

Model Number	A1020-080
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.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 of the reported lot revealed no other similar complaints.Based on the information provided, the balloon tip split was due the case circumstances and the anatomical conditions related to the circumstances of the procedure.In this case, it is likely that balloon tip interacted with the broken wire and the calcified vessel causing the tear.There is no indication of a product quality issue with respect to the design, manufacture, or labeling.The command guide wire referenced is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified, heavily tortuous lesion behind the knee (btk) with total occlusion.The command guide wire (gw) was advanced to the lesion with the support of a 2.0x80mm armada percutaneous transluminal angioplasty (pta) catheter; however, the gw could not cross and became stuck in the occlusion after attempting to go further subintimal.The tip of the command gw separated in the anterior tibial artery and no attempt was made to retrieve the tip.The armada 14 was inflated to a maximum of 7 atmospheres.No rupture noted, but a tear in the tip of the armada 14 from the tip to the beginning of the balloon was noted and was due to being advanced with the command guide wire in the heavily calcified lesion.A winn guide wire was able to cross the lesion but no other device, including a 2.0x120 mm armada, a 2.0x20 mm armada xt and a non-abbott balloon was able to cross despite the use of a non-abbott long introducer sheath.There was no reported clinically significant delay in the procedure.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
• MDR Report Key: 11440102
• Report Number: 2024168-2021-01833
• Device Sequence Number: 17139999
• Product Code: DQY
• UDI-Device Identifier: 08717648155697
• UDI-Public: 08717648155697
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/08/2021

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: 04/30/2023
• Device Model Number: A1020-080
• Device Catalogue Number: A1020-080
• Device Lot Number: 9112641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1