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

Model Number	B1070-040
Medical Device Problem Codes	Entrapment of Device (1212); Material Rupture (1546); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
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.
Event or Problem Description
It was reported that the procedure was to treat the external iliac artery with heavy calcification, moderate tortuosity and 100% stenosis.The 7x40 mm armada percutaneous transluminal angioplasty (pta) catheter was advanced to the lesion and resistance was noted with a previously implanted stent.The balloon was inflated twice to 12 atmospheres and ruptured.It was attempted to pull the device into the sheath but there was extreme resistance and the device was stuck.The device was able to be pulled to the puncture site and a cut down was performed to remove the device.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported balloon rupture was confirmed.The reported difficulty to advance and entrapment of device 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 query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported difficulty advancing the device, balloon rupture, entrapment of device and surgical intervention appear to be related to circumstances of the procedure.It was reported that the balloon dilatation catheter bdc interacted with the previously implanted stent resulting in the reported difficulty advancing the device.There was no leak noted during preparation or during the first initial inflation, which suggests a product quality issue did not contribute to the reported difficulties.In this case, it is likely that the balloon interacted with the heavily calcified anatomy and/or previously implanted stent, such that the balloon became damages and ruptured.In addition, the resistance noted during removal was likely the result of the ruptured balloon material catching on the anatomy and/or accessory device during removal and becoming stuck.A cut down procedure was performed to successfully remove the device.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: 20408919
• Report Number: 2024168-2024-11904
• Device Sequence Number: 19727567
• Product Code: LIT
• UDI-Device Identifier: 08717648154782
• UDI-Public: (01)08717648154782(17)270731(10)40201G1
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2024

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: B1070-040
• Device Catalogue Number: B1070-040
• Device Lot Number: 40201G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO DESTINATION 6F-45CM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown