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

Model Number	B1070-200
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed one manufacturing nonconformity that would have contributed to this complaint.However, it was determined to be an isolated event and not product quality issue.Additionally, a review of the complaint history of the reported lot revealed no other incidents.Based on the information provided, a conclusive cause for the reported difficulty could not be determined.It may be possible that the rupture occurred due to interaction with lesion or associated devices during use; however, without having the device to examine, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a lesion in an arteriovenous (av) fistula.The 7x200mm armada 35 balloon dilatation catheter (bdc) was advanced without issue for pre-dilatation; however, during the second inflation the balloon ruptured at rated burst pressure, 13 atmospheres.The bdc was removed without issue and a non-abbott bdc was used to complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

• 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: 11355831
• Report Number: 2024168-2021-01349
• Device Sequence Number: 11588873
• Product Code: LIT
• UDI-Device Identifier: 08717648154843
• UDI-Public: 08717648154843
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• 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): 02/19/2021

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: 09/30/2023
• Device Model Number: B1070-200
• Device Catalogue Number: B1070-200
• Device Lot Number: 00418G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR