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

Model Number	1013470-180
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
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 similar incidents and/or complaints reported from this lot.The device was prepped prior to use with no issues, which would suggest that the device was not damaged prior to use.The investigation determined the reported balloon rupture appears to be related to operational circumstances of the procedure.It is likely that during advancement the balloon outer surface became damaged and/or compromised against the calcified anatomy or other devices used resulting in the balloon rupture at 8 atmospheres during the first inflation.There is no indication of a product quality issue with respect to manufacture, design, or labeling.The 6.0 x 150 mm armada dilatation catheter referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the calcified superficial femoral artery (sfa).The 6.0 x 150 mm armada dilatation catheter was advanced to the target lesion without difficulty.On the first inflation, the balloon ruptured at 8 atmospheres (atm).The device was removed without difficulty.The 6.0 x 180 mm armada dilatation catheter was then advanced to the target lesion without difficulty; however, on the first inflation, this device also ruptured at 8 atm.The device was removed without difficulty.There was no adverse patient effect or a clinically significant delay in procedure.No additional information was provided.

• 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: 12564097
• Report Number: 2024168-2021-08816
• Device Sequence Number: 1453274
• Product Code: LIT
• UDI-Device Identifier: 08717648208454
• UDI-Public: 08717648208454
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 10/01/2021

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: 11/30/2022
• Device Model Number: 1013470-180
• Device Catalogue Number: 1013470-180
• Device Lot Number: 9062141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1