MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	1013470-150
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
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 performed to treat a lesion in the right superficial femoral artery.A 6x150mm armada 18 percutaneous transluminal angioplasty (pta) catheter was advanced without resistance, and the balloon ruptured during the first inflation at 8 atmospheres.The device was removed without issue, and an unspecified balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional inspections were 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 or relabeled lot that would have contributed to this event.Based on the review of similar incident(s) there is no indication of a lot specific product quality issue.In this case, the device was prepped prior to use without any leak 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 operational circumstances of the procedure.In this case, it is likely that the balloon interacted with the anatomy causing damage to the outer surface of the balloon resulting in a puncture like balloon rupture during the first inflation at 8 atmospheres as reported.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• Brand Name: ARMADA 18 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11738466
• Report Number: 2024168-2021-03600
• Device Sequence Number: 3192289
• Product Code: LIT
• UDI-Device Identifier: 08717648208447
• UDI-Public: 08717648208447
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151317
• 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,Followup
• Report Date (Section B): 06/01/2021

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: 1013470-150
• Device Catalogue Number: 1013470-150
• Device Lot Number: 0121141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1