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

Model Number	B2120-040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The additional armada 35 device referenced is filed under a separate medwatch report number.Na.
Event or Problem Description
It was reported that the procedure was to treat a common iliac artery.A 12x40mm armada 35 balloon was advanced to the lesion without resistance.Once at the lesion, the balloon was inflated once at 3-4 atmospheres (atm) and ruptured circumferentially.The device was withdrawn without issue.Then a 12x60mm armada 35 balloon was advanced to the lesion without resistance.Once at the lesion, the balloon was inflated once at 3-4 atmospheres (atm) and ruptured circumferentially.The device was attempted to be removed but met resistance with the anatomy and could not be removed completely.Therefore surgical intervention was performed to successfully remove the device.A non-abbott balloon was used to successfully complete the procedure.There was a clinically significant delay reported.No additional information was provided.
Event or Problem Description
It was reported that the procedure was to treat a common iliac artery.A 12x40mm armada 35 balloon was advanced to the lesion without resistance.Once at the lesion, the balloon was inflated once at 3-4 atmospheres (atm) and ruptured circumferentially.The device was withdrawn without issue.Then a 12x60mm armada 35 balloon was advanced to the lesion without resistance.Once at the lesion, the balloon was inflated once at 3-4 atmospheres (atm) and ruptured circumferentially.The device was attempted to be removed but met resistance with the anatomy and could not be removed completely.Therefore surgical intervention was performed to successfully remove the device.A non-abbott balloon was used to successfully complete the procedure.There was a clinically significant delay reported.Subsequent to the initially filed mdr, device analysis noted that the inner member for the 12x40mm armada 35 was separated and the proximal balloon marker appeared to be dislodged.The account could not confirm device analysis findings but confirmed that no part of the device remained in the anatomy.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis and scanning electron microscopy (sem) analysis was performed on the returned device and noted that the inner member for the 12x40mm armada 35 was separated and the proximal balloon marker appeared to be dislodged.The reported balloon 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.Additionally, a review of the complaint history identified no other complaints reported from this lot.Based on the reported information, evaluation of the returned unit and sem analysis, the investigation determined that the reported difficulties were likely due to circumstances of the procedure.It is likely that the balloon rupture was the result of interaction with the heavily calcified lesion.The additional damages noted to the returned unit and separation likely occurred during removal of the ruptured device from the anatomy.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

• 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: 11578981
• Report Number: 2024168-2021-02452
• Device Sequence Number: 16907269
• Product Code: LIT
• UDI-Device Identifier: 08717648155550
• UDI-Public: 08717648155550
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup
• Report Date (Section B): 06/16/2021

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: 02/28/2023
• Device Model Number: B2120-040
• Device Catalogue Number: B2120-040
• Device Lot Number: 90910G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Initial Date Received by Manufacturer: 03/07/2021
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 03/27/2021
• Supplement Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1