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

Model Number	B1060-150
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	10/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.D4: a partial udi was provided as the lot number is not known.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the superficial femoral artery (sfa).A 6x150mm armada 35 balloon dilatation catheter (bdc) was used for dilating the vessel; however, the balloon was noted to rupture during its second inflation at 12atm.Resistance was noted during the bdc removal and a surgical cut down was performed to remove the device and complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported balloon rupture was confirmed; however, 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 device analysis, a definitive cause for the reported balloon rupture could not be determined; however, the reported difficulty removing the device and surgical intervention appear to be related to circumstances of the procedure.Balloon material ruptures can be affected by numerous factors including, but not limited to, balloon damage during processing of the balloon material, materials, inflation technique, and interactions with other devices or lesion calcification.In this case, it is likely that the balloon interacted with the patient¿s challenging anatomy such that the balloon became damaged and ruptured; however, since limited information was provided, a conclusive cause cannot be determined.Additionally, the resistance reported during removal likely result from the ruptured balloon material catching on the patient¿s anatomy and/or accessory devices during removal as the rupture likely did not allow the balloon material to refold properly.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Additional information: d4: lot number updated from unknown to 40118g1.

• 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: 20509774
• Report Number: 2024168-2024-12429
• Device Sequence Number: 13033571
• Product Code: LIT
• UDI-Device Identifier: 08717648154744
• UDI-Public: (01)08717648154744(17)270630(10)40118G1
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/02/2024

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: B1060-150
• Device Catalogue Number: B1060-150
• Device Lot Number: 40118G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2024
• 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