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

Model Number	B1100-040
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2020
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 to treat a shunt with calcified stenosis.The armada 35 was advanced and during the first inflation at 12 atmospheres, the balloon ruptured radially around the shoulder of the balloon and was in two pieces.The balloon pieces, wire and sheath were removed as a single unit.There was no adverse patient effect or a clinically significant delay.The shunt was re-accessed and the procedure completed.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis and sem analysis was performed on the returned device.The reported balloon rupture and separation was confirmed.The difficulty removing was not tested due to the condition of the device.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 case related circumstances.It is likely that the balloon rupture initiated longitudinal and was the result of interaction with the calcified lesion or associated devices.In addition, the resistance noted during removal and radial separation of the balloon was likely the result of the ruptured balloon material catching on the introducer sheath or anatomy during removal.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: 10939141
• Report Number: 2024168-2020-10145
• Device Sequence Number: 584181
• Product Code: LIT
• UDI-Device Identifier: 08717648154942
• UDI-Public: 08717648154942
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 01/19/2021

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: 08/31/2023
• Device Model Number: B1100-040
• Device Catalogue Number: B1100-040
• Device Lot Number: 00323G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1