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

Model Number	B1050-040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during device preparation, the 5.00x40mm armada 35 balloon dilatation catheter (bdc) was soaked and air aspiration was performed prior to use.The procedure was to treat a 80% stenosed de novo lesion in the arteriovenous (av) fistula with mild calcification and mild tortuosity.The bdc was advanced to the target lesion and the balloon was inflated; however, during the second inflation at 15 atmospheres (atm), the balloon ruptured.The bdc was removed from the patient.There was no adverse patient effect and no clinically significant delay reported in the procedure.Another same size armada balloon was used to successfully complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.Na.
Additional Manufacturer Narrative
The device was not returned for evaluation.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 was unable to determine a conclusive cause for the reported balloon rupture.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.D4: lot number updated from 20720g2 to 20720g1.D9, h3 - it was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was discarded and is not available for evaluation.
Event or Problem Description
Subsequent to the initial report being filed.Return device analysis found there were no damages noted to the bdc.The account confirmed that the incorrect bdc was returned and the reported bdc was discarded.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
• 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: 16516643
• Report Number: 2024168-2023-02464
• Device Sequence Number: 6129190
• Product Code: LIT
• UDI-Device Identifier: 08717648154607
• UDI-Public: 08717648154607
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2023

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: 12/31/2025
• Device Model Number: B1050-040
• Device Catalogue Number: B1050-040
• Device Lot Number: 20720G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• 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
• Patient Sex: Unknown