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

Model Number	B1100-060
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.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 an unspecified lesion.The 10x60mm armada 35 balloon suddenly deflated during inflation [balloon rupture}.There were no adverse patient effects reported and a clinically significant delay in the procedure was not reported.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned unit and noted the shaft was separated near the hub and the inner member was separated at the proximal balloon seal.The balloon rupture was 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 investigation was unable to determine the cause for the balloon rupture.It is possible the balloon was damaged during the insertion process leading to the rupture.The remaining damage of material separation, bent, stretched, and torn material appear to be related to the circumstances of the procedure post balloon rupture; as the damage is consistent with a high tensile force from pulling.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.
Event or Problem Description
It was reported that the procedure was performed to treat an unspecified lesion.The 10x60mm armada 35 balloon suddenly deflated during inflation.There were no adverse patient effects reported and a clinically significant delay in the procedure was not reported.The sudden balloon deflation will be conservatively interpreted as a balloon rupture.Subsequent to filing the initial report, the device analysis indicated the shaft was separated near the hub and the inner member was separated at the proximal balloon seal.The proximal and distal portions were returned.Follow-up was performed; however, no additional information was provided.It is unknown if the separation occurred in the patient or how the distal portion was retrieved.However, there was no medical intervention reported.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: 11148110
• Report Number: 2024168-2021-00290
• Device Sequence Number: 11635058
• Product Code: LIT
• UDI-Device Identifier: 08717648154959
• UDI-Public: 08717648154959
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2021

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: B1100-060
• Device Catalogue Number: B1100-060
• Device Lot Number: 00430G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1