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

Model Number	B2070-040
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional armada 18 device is filed under separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified superficial femoral artery (sfa).The 3.0x40mm armada 18 balloon dilatation catheter (bdc) ruptured during the first inflation at 4 atmospheres (atm).The bdc was removed without issue and a 7.0x40mm armada 35 bdc was inflated to 4 atms; however, ruptured during the first inflation.The armada 35 bdc was removed; however, resistance was felt with the 6fr sheath.The balloon was noted to still remain in the patient.Snaring of the separated portion was attempted; however, not successful.The patient was taken into surgery to remove the balloon; however, it is unknown if the separated portion was successfully removed.There is no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported balloon rupture and separation was confirmed.The difficulty removing was not tested due to the condition of the device.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 indication of a lot specific product quality issue.The investigation determined that the reported balloon rupture, difficulty removing, and separation resulting in unexpected medical intervention and surgical intervention were likely due to circumstances of the procedure.It is likely that the balloon rupture was the result of interaction with the heavily calcified anatomy.There were no leaks reported during preparation, suggesting that the damage was not pre-existing.In addition, the difficulty reported during removal and separation of the balloon was likely the result of the ruptured balloon material catching on the introducer sheath during removal causing the balloon material to tear and separate.There is no indication of a product quality issue with respect to the 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: 15749599
• Report Number: 2024168-2022-11336
• Device Sequence Number: 6203434
• Product Code: LIT
• UDI-Device Identifier: 08717648155352
• UDI-Public: 08717648155352
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2022

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: 08/31/2025
• Device Model Number: B2070-040
• Device Catalogue Number: B2070-040
• Device Lot Number: 20328G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/14/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6FR SHEATH.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 97 KG