MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ARMADA; PERIPHERAL DILATATION CATHETER

Model Number	B2070-080
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	10/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat an 80% re-stenosed av fistula.The 7x80mm armada 35 balloon dilatation catheter (bdc) was advanced to the target lesion and the balloon was inflated once; however, the balloon ruptured at 12 atmospheres (atm).Therefore, the bdc was removed and resistance was noted with the sheath.A piece of the balloon separated in the anatomy and cut down surgery was performed to remove the separated piece of balloon.There was no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported balloon rupture and separation were confirmed.The reported difficulty to remove could not be replicated in a testing environment as it was based on operational circumstances.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported balloon rupture could not be determined; however, the reported separation, difficulty removing the device, surgical intervention and unexpected medical intervention appear to be related to circumstances of the procedure.Based on the results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ARMADA
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 20626017
• Report Number: 2024168-2024-13065
• Device Sequence Number: 8792794
• Product Code: LIT
• UDI-Device Identifier: 08717648155376
• UDI-Public: (01)08717648155376(17)271031(10)40522G1
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 11/06/2024

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 Model Number: B2070-080
• Device Catalogue Number: B2070-080
• Device Lot Number: 40522G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2024
• 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
• Patient Sex: Unknown