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

Model Number	B1120-080
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported balloon rupture was confirmed.There was a longitudinal balloon rupture at the proximal balloon taper extending distally, confirming the reported rupture.The balloon was separated distal from the proximal balloon tapper and the inner member was separated proximal from the proximal balloon tapper.The separated portions of the balloon including the tip, balloon markers, and inner member were not returned.It was reported by the account that the balloon was cut off from the wire so the wire could be re-advanced into the patient, which explains the material separation.The reported difficulty removing the device from the guide wire and introducer sheath could not be replicated in a testing environment due to the condition of the returned 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 similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported complaints.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the brachiocephalic vein.A 12x80mm armada 35 balloon dilatation catheter (bdc) was advanced to the target lesion without issue and inflated one time to unknown atmospheres (atm), when the balloon ruptured.During removal, the balloon became stuck with the sheath and an unspecified wire.The balloon catheter was able to be removed from the sheath, with the wire as a single unit.The balloon was then cut off from the wire so the wire could be re-advanced into the patient.The procedure was completed with a new unspecified balloon device.There was no reported adverse patient effect and no clinically significant delays in the procedure.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: 16433140
• Report Number: 2024168-2023-01877
• Device Sequence Number: 3151010
• Product Code: LIT
• UDI-Device Identifier: 08717648155000
• UDI-Public: 08717648155000
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 02/23/2023

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: B1120-080
• Device Catalogue Number: B1120-080
• Device Lot Number: 20715G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2022
• 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 Age: 56 YR
• Patient Sex: Male
• Patient Weight: 67 KG