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

Model Number	B2070-040
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/02/2020
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 with mild calcification, mild tortuosity, and 80% stenosis in the arteriovenous fistula.Although no resistance noted during advancement, a 7.0 x 40mm armada 35 balloon ruptured during first inflation at rated burst pressure.The balloon dilatation catheter was withdrawn without resistance; however, the proximal shaft separated into two pieces after being removed from the anatomy.Another same size armada 35 balloon was used to complete the procedure.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the initial report, additional reported information indicates that the distal balloon separated into two pieces following the rupture and after being removed from the patient's anatomy (not the proximal shaft as previously reported).No additional information was provided.
Additional Manufacturer Narrative
Visual and scanning electron microscopy (sem) analysis was performed on the returned unit.The balloon rupture and separation were 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 complaints.Based on the information provided, the balloon rupture and separation appear to be due to case circumstances.It is likely that the balloon was damaged during the insertion process into the arteriovenous fistula, leading to the rupture and radial tear.The subsequent separation was likely induced during removal.The inner member separation and tip separations are related to the circumstances of the procedure.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: 10987990
• Report Number: 2024168-2020-10401
• Device Sequence Number: 3478749
• Product Code: LIT
• UDI-Device Identifier: 08717648155352
• UDI-Public: 08717648155352
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2021

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: 08/31/2023
• Device Model Number: B2070-040
• Device Catalogue Number: B2070-040
• Device Lot Number: 00302G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1