MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	1013465-060
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device is expected to be returned for investigation.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 lesion located in the peroneal artery.The armada 18 balloon catheter was advanced to the lesion without issue, but ruptured during the second inflation at 16 atmospheres and part of the balloon detached on the plaque.A snare device was used to remove the detached portion.A supera stent was implanted to complete the procedure.There was no adverse patient effect and no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported balloon rupture and separations 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 identified no other similar incidents and/or complaints from this lot.In this case, it was reported that the balloon was inflated a second time to 16 atmospheres.It should be noted that the armada 18 instruction for use (ifu) states: ¿inflation in excess of the rated burst pressure may cause the balloon to rupture.Use of a pressure monitoring device is recommended.¿ the rated burst pressure for this device is 14 atmospheres as indicated on the product label.In this case, the reported inflation above rbp did not contribute to the ifu violation as the balloon inflated successfully the first time.The investigation determined the reported complaints, additional treatment, removal of foreign body and foreign body in patient appear to be related to operational context.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
Event or Problem Description
Subsequent to the previously filed report.It was confirmed that part of the balloon detached; part of the material was able to be removed, but the physician was not able to remove the balloon marker and deployed a supera stent to compress the marker against the artery wall.

• Brand Name: ARMADA 18 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11971595
• Report Number: 2024168-2021-04861
• Device Sequence Number: 4179205
• Product Code: LIT
• UDI-Device Identifier: 08717648207877
• UDI-Public: 08717648207877
• Combination Product (Y/N): N
• PMA/510(K) Number: K151317
• 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): 08/16/2021

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: 10/31/2023
• Device Model Number: 1013465-060
• Device Catalogue Number: 1013465-060
• Device Lot Number: 0050841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 08/16/2021
• 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: 79 YR