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

Model Number	B1120-040
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned to abbott vascular for analysis.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 no other incidents and/or complaints reported from this lot.In this case, the device was prepped prior to use without ruptures noted, which would suggest that the device was not damaged prior to use.The investigation determined the reported difficulty to advance, difficulty to remove, and balloon rupture appear to be related to operational circumstances of the procedure.Based on the reported information, in this case, during advancement the balloon catheter encountered resistance with the 99% stenosed, heavily calcified, heavily tortuous anatomy resulting in the difficulty to advance and remove.It is likely that during advancement and/or re-advancement, the balloon outer surface became compromised and/or damaged against the anatomy resulting in the reported balloon rupture.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that the procedure was to treat a de novo, 99% stenosed, heavily calcified, heavily tortuous vessel in the femoral artery.The 12.0x40mm armada 35 percutaneous transluminal angioplasty (pta) catheter failed to cross the targeted lesion due to the anatomy on the first attempt and there was resistance with the anatomy during removal.Plain old balloon angioplasty (poba) was performed and the armada 35 was able to advance on this attempt, however, during inflation it failed to hold the pressure.It was noted under fluoroscopic guidance that there was a leak of contrast in the balloon.Another armada 35 was able to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in 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: 12395253
• Report Number: 2024168-2021-07723
• Device Sequence Number: 17157771
• Product Code: LIT
• UDI-Device Identifier: 08717648154980
• UDI-Public: 08717648154980
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/31/2021

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: 09/30/2023
• Device Model Number: B1120-040
• Device Catalogue Number: B1120-040
• Device Lot Number: 00429G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1