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

Model Number	A2030-200
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified de novo lesion in the popliteal artery.The 3.0x200 mm armada 14 percutaneous transluminal angioplasty (pta) balloon catheter was advanced to the lesion without resistance.The pta balloon was inflated once for 180 seconds and the balloon ruptured at 8 atmospheres.Another same size armada pta catheter was used to complete the procedure.There were no adverse patient effects and there was no reported significant delay.No additional information was provided.
Additional Manufacturer Narrative
A visual and functional inspection was performed on the returned device and the reported balloon rupture was confirmed.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 incidents and/or complaints reported from this lot.The investigation determined the reported balloon rupture appears to be related to operational circumstances of the procedure.It is likely that during advancement and/or inflation, the balloon outer surface became damaged or compromised against the heavily calcified resulting in the reported balloon rupture during the first inflation at 8 atmospheres.The noted scratch at the rupture site also suggests interaction causing damage to the outer surface of the balloon material.The noted flat balloon was likely caused by during deflation against the anatomy.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 12155860
• Report Number: 2024168-2021-05989
• Device Sequence Number: 11803825
• Product Code: DQY
• UDI-Device Identifier: 08717648156113
• UDI-Public: 08717648156113
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 08/30/2021

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: 07/31/2024
• Device Model Number: A2030-200
• Device Catalogue Number: A2030-200
• Device Lot Number: 1020941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1