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

Model Number	A2025-120
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis.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.In this case, the device was prepped prior to use without any leaks or ruptures noted, which would suggest that the device was not damaged prior to use.The investigation determined the reported balloon rupture appears to be related to case circumstances of the procedure.In this case, based on the reported information, it is likely that balloon outer surface became compromised and/or damaged during dilatation against the calcified lesion resulting in the balloon rupture at 10 atmospheres.There is no indication of a product quality issue with respect to manufacture, design, or labeling.The additional device referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that this was a peripheral percutaneous intervention on the peroneal artery, calcified lesion.An armada balloon catheter advanced to the lesion site without an issue reported.Dilatation was performed at 8 atmospheres when the balloon burst.The device was removed without issue.Another armada dilatation catheter advanced to the lesion without an issue noted.During balloon dilatation at 10 atmospheres, this balloon also burst.The device was removed without further issues.Another armada catheter was successfully used in replacement.There were no adverse patient effects and there was no clinically significant delay.No additional information was provided regarding this issue.

• 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: 12615692
• Report Number: 2024168-2021-09120
• Device Sequence Number: 12115953
• Product Code: DQY
• UDI-Device Identifier: 08717648156045
• UDI-Public: 08717648156045
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2021

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: 05/31/2024
• Device Model Number: A2025-120
• Device Catalogue Number: A2025-120
• Device Lot Number: 0120841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 76