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

Model Number	B1140-060
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual inspection was performed on the returned balloon catheter and the reported rupture was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the review of similar incidents there is no indication of a lot specific product quality issue.In this case, the device was prepped prior to use and inflated multiple without any leaks or ruptures noted, which would suggest that the device was not damaged prior to use.The investigation determined the reported balloon rupture appears to be related to case circumstances of the procedure.In this case, based on the reported information, it is likely that during multiple inflations, the balloon outer surface became compromised and/or damaged against the anatomy and or other devices used, resulting in the balloon rupture at 4 atmospheres during the third inflation.There is no indication of a product quality issue with respect to manufacture, design, or labeling.The other armada balloon mentioned is filed under a different mfr number.
Event or Problem Description
It was reported that the procedure was performed to treat target lesions in the right and left iliac veins.The first armada dilatation catheter was advanced into the right iliac vein without difficulty and inflated three times.On the third inflation, the balloon was inflated to 4 atmospheres (atm) and ruptured.The device was removed without difficulty and there was no adverse patient effect.Dilatation was completed using a 16 x 60 mm non-abbott dilatation catheter.The second armada dilatation catheter was advanced into the left iliac vein without difficulty and inflated one time, to 2 atm; however, a balloon rupture occurred.There was no difficulty removing the device and no adverse patient effect.Dilatation was completed using the 16 x 60 mm non-abbott dilatation catheter.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: 12544641
• Report Number: 2024168-2021-08715
• Device Sequence Number: 5174048
• Product Code: LIT
• UDI-Device Identifier: 08717648155031
• UDI-Public: 08717648155031
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 09/28/2021

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: 08/31/2024
• Device Model Number: B1140-060
• Device Catalogue Number: B1140-060
• Device Lot Number: 10309G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 71