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

Catalog Number	B1120-040
Medical Device Problem Codes	Break (1069); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
Type of Reportable Event	Malfunction
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 subclavian vein that was moderately calcified, moderately stenosed.The 12x40mm armada 35 ruptured during the second inflation at 10 atmospheres (atms), both inflation cycles were at 10 atms.During removal the balloon separated in the 6fr sheath.The separated portion was removed without issue, as it remained in the sheath.Another armada 35 same size was used to continue the procedure.There was no adverse patient effects and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported balloon rupture was confirmed; however, the reported separation/break could not be 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 similar incidents and/or complaints from this lot.The investigation determined the reported balloon rupture appears to be related to operational context; however, a conclusive cause for the reported separation/break could not be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.B5 - describe event or problem updated.H6: device code 1562 removed and 1069 added.
Event or Problem Description
Subsquently, after the initial was filed device return analysis confirmed that the device was not separated.It was noted that the armada 35 was noted to break during removal in the 6fr sheath; however, not into two pieces.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: 18380102
• Report Number: 2024168-2023-14332
• Device Sequence Number: 18092165
• Product Code: LIT
• UDI-Device Identifier: 08717648154980
• UDI-Public: 08717648154980
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 03/05/2024

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 Catalogue Number: B1120-040
• Device Lot Number: 30926G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2023
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2023
• 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: 6FR SHEATH.
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 50 KG