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

Model Number	1013465-200
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The additional armada device referenced is filed under separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a moderately tortuous, heavily calcified right anterior tibial and part of the distal popliteal arteries.Atherectomy was performed prior to the procedure starting.Then an armada balloon was advanced to the lesion without issue, inflated once when the balloon ruptured at 7 atmospheres (atm).Another armada was advanced and the same issue occurred.The devices were retrieved without issue.The right anterior lesion was deemed good, and a 4x100mm armada was used to successfully finish the distal popliteal lesion.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported balloon rupture was confirmed.The noted tear also likely contributed to operational context.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 one other similar incident reported from this lot.However, this is related to the same event and not a product quality issue.The investigation determined that case circumstances are the likely cause for the reported difficulties.It is likely that the rupture occurred due to interaction with the heavily calcified right anterior tibial and part of the distal popliteal arteries causing damage to the outer surface of the balloon resulting in rupture during inflation.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• 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: 11645584
• Report Number: 2024168-2021-02982
• Device Sequence Number: 11547786
• Product Code: LIT
• UDI-Device Identifier: 08717648207938
• UDI-Public: 08717648207938
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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: 03/31/2024
• Device Model Number: 1013465-200
• Device Catalogue Number: 1013465-200
• Device Lot Number: 0102941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1