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

Model Number	B1120-040
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	01/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been received.Investigation has not yet been completed.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the during post dilatation using an armada balloon catheter, the balloon ruptured longitudinal during first inflation at 10 atmosphere.However, during removal of the balloon catheter, the balloon got caught with the implanted stent and the balloon separated from the catheter.A snare device was used to retrieve the separated balloon from the patient anatomy.There was nothing left inside the patient anatomy.The procedure was completed, and the patient remained stable.No additional information was provided.
Additional Manufacturer Narrative
Visual 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 indication of a lot specific product issue.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 lesion calcified 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 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: 9717642
• Report Number: 2024168-2020-01542
• Device Sequence Number: 3220935
• Product Code: LIT
• UDI-Device Identifier: 08717648154980
• UDI-Public: 08717648154980
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: B1120-040
• Device Catalogue Number: B1120-040
• Device Lot Number: 90826G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR