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

Model Number	B2050-200
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.It should be noted that the instructions for use (ifu), pta, armada 35 / armada 35 ll, global, ce, states: gentle counterclockwise twisting motion of the balloon may ease withdrawal through the sheath.If the balloon cannot be withdrawn through the sheath, withdraw the catheter and the sheath as one unit.The deviation related to using force during removal does not appear to have caused or contributed to the reported event.Based on the information provided a conclusive cause for the reported balloon rupture cannot be determined., additionally, the resistance encountered during removal and separation likely occurred due to the ruptured balloon material catching on the introducer sheath during removal.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 de novo lesion in the heavily calcified, moderately tortuous, 80% stenosed left superficial femoral artery.A non-abbott 6f sheath was advanced with a 5x200mm armada 35 percutaneous transluminal angioplasty (pta) catheter, and the balloon ruptured during the first inflation at nominal pressure.The pta catheter and sheath faced resistance with each other during removal, so force was applied.An unspecified armada 35 balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.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: 12533887
• Report Number: 2024168-2021-08637
• Device Sequence Number: 1239965
• Product Code: LIT
• UDI-Device Identifier: 08717648155239
• UDI-Public: 08717648155239
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Report Date (Section B): 09/27/2021

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: 11/30/2024
• Device Model Number: B2050-200
• Device Catalogue Number: B2050-200
• Device Lot Number: 10609G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6F CROSSOVER SHEATH