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

Model Number	B1070-080
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.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 arteriovenous fistula (avf).A 7x80mm armada 35 balloon catheter was prepared per the instructions for use.The balloon catheter was being used to dilate the lesion; however, the balloon ruptured at 14 atmospheres (atms).The balloon catheter did not resolve the fistula stenosis due to the tight stenosis.A 7x40mm armada balloon catheter was inflated to 15 atms to treat the waist and a non-abbott stent was deployed to successfully treat the fistula stenosis.Final angiography showed a widely patent proximal avf and good flow.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.The reported balloon rupture was confirmed.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 incidents.The investigation determined that the reported balloon ruptures were likely due to case related circumstances.It is likely that the balloon interacted with the lesion site causing damage to the outer surface of the balloon material which subsequently ruptured during inflation.The scratch noted at the rupture indicates interaction to the outer surface material occurred.The noted leak is a result of the anatomy interaction during insertion.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: 10298730
• Report Number: 2024168-2020-06015
• Device Sequence Number: 16818631
• Product Code: LIT
• UDI-Device Identifier: 08717648154805
• UDI-Public: 08717648154805
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 08/12/2020

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: 07/31/2023
• Device Model Number: B1070-080
• Device Catalogue Number: B1070-080
• Device Lot Number: 00224G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 67