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

Model Number	B1060-100
Medical Device Problem Codes	Entrapment of Device (1212); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2021
Type of Reportable Event	Serious Injury
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.Based on the information provided, a conclusive cause for the reported balloon rupture, entrapment and material separation resulting in surgery could not be determined.It may be possible that the balloon rupture was the result of interaction with anatomy or associated devices during inflation; however, this could not be determined.Additionally, the balloon entrapment and separation likely occurred due to the ruptured balloon material catching on the anatomy or introducer sheath during removal resulting in surgical procedure to remove the separated material.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a mildly calcified, mildly tortuous brachial vein.The 6x100mm armada 35 balloon was inflated to nominal and it ruptured on the first inflation at 6atm.The balloon separated and got stuck in the patient.A cutdown was performed to retrieve the separated balloon.A same size non-abbott balloon was used to treat the target lesion.There was no adverse patient sequela 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: 11701175
• Report Number: 2024168-2021-03357
• Device Sequence Number: 3535022
• Product Code: LIT
• UDI-Device Identifier: 08717648154720
• UDI-Public: 08717648154720
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/21/2021

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: 08/31/2023
• Device Model Number: B1060-100
• Device Catalogue Number: B1060-100
• Device Lot Number: 00305G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 04/21/2021
• 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