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

Catalog Number	B2070-040
Medical Device Problem Codes	Entrapment of Device (1212); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified lilac artery.The 7x40mm armada 35 balloon dilatation catheter (bdc) was advanced with a 7f catheter once at the lesion the balloon was inflated at 6 atmosphere and ruptured.It was not possible to retrieve the balloon threw the catheter as several attempts were made.The balloon with the guiding catheter was removed via cut down.It was noted during the cut down the balloon had to be cut into separate pieces in order to remove the device.There was no adverse patient sequela; however, clinically significant delay was noted.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported balloon rupture was confirmed.The reported entrapment of device could not be replicated in a testing environment as it was based on operational circumstances.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 from this lot.The investigation determined the reported balloon rupture, entrapment of device, surgical intervention and delay to treatment/therapy appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 17765531
• Report Number: 2024168-2023-10167
• Device Sequence Number: 6664283
• Product Code: LIT
• UDI-Device Identifier: 08717648155352
• UDI-Public: 08717648155352
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2023

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: 09/30/2026
• Device Catalogue Number: B2070-040
• Device Lot Number: 30421G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7F CATHETER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown