MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	B2050-100
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.Na.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the superficial femoral artery.An unspecified stent was implanted and the armada 35 dilatation catheter balloon was used for post-dilatation.During use, the balloon ruptured at an unknown pressure.There was no adverse patient effect and no clinically significant delay.A second same device was used.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported rupture was confirmed as a pinhole was noted on the balloon as well as scratches noted near the pinhole.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 incidents.The investigation determined that the reported balloon rupture was likely due to case related circumstances.It is likely that the balloon interacted with the anatomy causing damage to the outer surface of the balloon material which subsequently ruptured during inflation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10417889
• Report Number: 2024168-2020-06831
• Device Sequence Number: 2676454
• Product Code: LIT
• UDI-Device Identifier: 08717648155208
• UDI-Public: 08717648155208
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2020

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: 05/31/2023
• Device Model Number: B2050-100
• Device Catalogue Number: B2050-100
• Device Lot Number: 91204G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1