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

Model Number	B2060-150
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2020
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 the procedure was to treat a 50% stenosed, mildly tortuosity, and moderately calcified de novo lesion in the superficial femoral artery.A 6.0x150mm armada 35 balloon dilatation catheter (bdc) was prepped outside the anatomy prior to use without any issues.The bdc was advanced without resistance and the balloon was inflated once; however, ruptured below pressure at 14 atmospheres.The procedure was successfully completed with another same size armada 35 bdc.There were no adverse patient effects reported and no clinically significant delay in the procedure reported.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported balloon rupture was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other complaints.The investigation determined that the reported difficulties were likely due to circumstances of the procedure.It is likely that the balloon rupture occurred due to interaction with the calcified lesion causing damage to the outer surface of the balloon material.There were no leaks noted during preparation indicating that the damage was not pre-existing.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: 10530301
• Report Number: 2024168-2020-07669
• Device Sequence Number: 16978470
• Product Code: LIT
• UDI-Device Identifier: 08717648155314
• UDI-Public: 08717648155314
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2020

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: 06/30/2022
• Device Model Number: B2060-150
• Device Catalogue Number: B2060-150
• Device Lot Number: 90116G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1