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

Model Number	B1080-080
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device is not returning for analysis.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 a lesion in the left popliteal vein.An 8x80mm armada 35 percutaneous transluminal angioplasty (pta) catheter was advanced without resistance, but the balloon ruptured during the first inflation below rated burst pressure.The pta balloon had resistance with an unspecified guide wire during removal, so force was applied.A portion of the balloon had separated, so an unspecified stent was used to embed the separated portion and successfully complete the procedure.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 complaints.The armada 35 instructions for use states: do not advance the armada 35 / armada 35 ll pta catheter against significant resistance.The cause of resistance should be determined via fluoroscopy and remedial action taken.Although it was reported that extra force was used to remove the balloon catheter, the excess force seemed to be a reasonable clinical response to the difficulties encountered.Based on the information provided, a definitive cause could not be determined for the reported balloon rupture resulting in difficulty removing, material separation and unexpected medical intervention to embed the separated material.It is possible that the balloon rupture was the result of interaction with anatomy or associated devices.Additionally, the resistance encountered with the guide wire during removal and separation may have occurred due to the balloon material and inner member collapsing over the guide wire after the balloon ruptured; however, this could not be confirmed.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: 12578214
• Report Number: 2024168-2021-08914
• Device Sequence Number: 17016076
• Product Code: LIT
• UDI-Device Identifier: 08717648154881
• UDI-Public: 08717648154881
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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: 10/31/2024
• Device Model Number: B1080-080
• Device Catalogue Number: B1080-080
• Device Lot Number: 10504G1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 10/21/2021
• 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: 81 YR