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

Model Number	B1060-060
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned as it was discarded.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified stenosed iliac artery.A non-abbott j-wire was advanced to the lesion.Then a 6x60mm armada balloon was advanced to the lesion and when inflated it ruptured at an unspecified atmosphere.The device was then pinched and pulled off the guide wire, but did not completely come out as the proximal part of the balloon was still on the wire.The sheath was upsized to a 7fr sheath and both devices were able to be pulled out together (balloon stuck on guide wire).No additional information was provided.
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 and inflated twice prior to the rupture with no issue/ leak noted, which would suggest that a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported balloon rupture appears to be related to operational circumstances of the procedure.Based on the reported information, in this case, it is likely that after multiple inflations and/or repositioning, the balloon became compromised and/or damaged against the anatomy resulting in the reported balloon rupture during the third inflation at 10 atmospheres.The balloon rupture likely caused the inner member to lock the guide wire in place resulting in the difficulty to remove the guide wire.Additionally, the treatment appears to be related to the operational context of the procedure as the sheath was upsized to a 7fr sheath and both devices were able to be pulled out together.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 11057620
• Report Number: 2024168-2020-10844
• Device Sequence Number: 2975370
• Product Code: LIT
• UDI-Device Identifier: 08717648154706
• UDI-Public: 08717648154706
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2021

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: 09/30/2023
• Device Model Number: B1060-060
• Device Catalogue Number: B1060-060
• Device Lot Number: 00420G1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 01/04/2021
• 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: 6FR SHEATH; J-WIRE; 6FR SHEATH; J-WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 78