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

Model Number	B2100-040
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device 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.The device was prepped prior to use without any leak or ruptures noted, which would suggest that the device was not damaged prior to use.The investigation determined the reported balloon rupture, difficulty to remove, balloon separation and treatments appears to be related to operational circumstances of the procedure.In this case, it is likely that the balloon became compromised and/or damaged during advancement through the heavily calcified anatomy resulting in the reported balloon rupture.Due to the balloon rupture, the balloon did not properly refold likely resulting in the difficulty to remove with the anatomy.Manipulation against resistance ultimately resulted in the balloon separation and the use of a snare device to remove the separated segment of the balloon.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 armada 35 balloon dilatation catheter was advanced to the heavily calcified aorta without issue.During the first inflation, the balloon ruptured due to the heavy calcification.During removal, resistance was noted and the balloon separated from the balloon dilatation catheter.A snare was used to retrieve the balloon.There was no reported adverse patient effect or a 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: 12362696
• Report Number: 2024168-2021-07471
• Device Sequence Number: 14408374
• Product Code: LIT
• UDI-Device Identifier: 08717648155512
• UDI-Public: 08717648155512
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 08/24/2021

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: B2100-040
• Device Catalogue Number: B2100-040
• Device Lot Number: 10526G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 08/24/2021
• 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