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

Model Number	B2080-080
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a left femoral arteriovenous (av) graft.An 8x80mm armada 35 and 7x40mm armada 35 balloon dilatation catheter (bdc) were being used in the procedure and advanced separately to the av graft.Both balloons were inflated two to three times each, to 13 atmospheres (atm) when the balloons ruptured.In an attempt to pull the balloons back into the sheath for removal, a separation occurred.Some of the balloon pieces were removed from the anatomy with endoscopic forceps.The patient¿s entire anatomy was x-rayed to try to find the remaining broken portion of the balloon, but it was unable to be found.The patient came back to the operating room on the (b)(6) 2021; however, the outcome from that procedure is unknown.It was noted that ¿it is less likely that the balloons ruptured, but instead were snagged on stents that were already in place in the patient¿s leg¿.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.The other armada balloon is filed under a separate medwatch report number.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported balloon rupture and separation were 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 other complaints reported from this lot.The investigation determined that the reported difficulties and subsequent treatments were likely due to circumstances of the procedure.It is likely that the balloon ruptures were the result of interaction with the anatomy or arteriovenous (av) graft.There were no leaks reported during preparation and it was reported that the ruptures occurred during the second to third inflation, 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.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
• 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: 13311603
• Report Number: 2024168-2022-00719
• Device Sequence Number: 4944818
• Product Code: LIT
• UDI-Device Identifier: 08717648155451
• UDI-Public: 08717648155451
• 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): 02/23/2022

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: 01/31/2025
• Device Model Number: B2080-080
• Device Catalogue Number: B2080-080
• Device Lot Number: 10824G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/28/2021
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 116 KG