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

Model Number	B1100-060
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat the subclavian vein.The patient presented with a blood clot due to the narrowing of a previously implanted stent that was placed 6-7 years ago.A 6 french sheath was used and the 10x60mm armada balloon catheter had no resistance during advancement and was inflated once at 11 atmospheres (atms).However, the waste of the narrowing of the stent did not respond to the dilatation and the balloon ruptured.The guide wire port was flushed prior to use and the balloon was not soaked.The armada was prepared (air aspiration) outside the anatomy prior to use without any issues.The physician proceeded to remove the balloon but resistance was noted possibly by the remaining ribs (first and second rib removed from a previous procedure) during withdrawal.When resistance was felt, the balloon catheter was manipulated (advanced and retracted) to try and clear it from what was causing resistance.A little extra force was applied to remove it and the hypotube and the balloon separated from the rest of the catheter.A snare was used and it was confirmed that all the pieces were removed from the patient.A 7 french sheath was used and a non-abbott balloon was used but the stent still stayed narrow.The patient stayed in the hospital with a lytic catheter in place to treat the blood clot.The prolonged hospitalization was due to the treatment of the blood clot.There was no adverse patient sequela and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Medical device problem code (b)(4).The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
The device was not returned for evaluation.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 of the reported lot did not indicate a lot specific quality issue.It was reported by the account that the stent was previously placed approximately 6-7 years ago, and it appeared crushed.In this case, it is likely that the balloon interacted with the previously implanted stent such that the balloon became damaged and ruptured and subsequently the ruptured balloon became caught on the stent and resulted in the reported difficulty during removal.When resistance was felt, the balloon catheter was manipulated (advanced and retracted) to try and clear it from what was causing resistance.A little extra force was applied to remove it and the hypotube and the balloon separated from the rest of the catheter.It should be noted that the percutaneous transluminal angioplasty catheter (pta), armada 35/ armada 35ll global, ce, instruction for use (ifu) states: maintaining a vacuum in the balloon, withdraw the catheter.Note: gentle counterclockwise twisting motion of the balloon may ease withdrawal through the sheath or from the percutaneous entry site.If the balloon cannot be withdrawn through the sheath, withdraw the catheter and sheath as one unit.In this case, the physician did not follow the instructions for use.Instead of using gentle counterclockwise twisting motion to remove the device, force was applied resulting in the reported separation.Additional treatment with a snare device was performed and it was confirmed that all the pieces were removed from the patient.The investigation determined the reported balloon rupture, difficulty removing the device, removal of foreign body and unexpected medical intervention appear to be related to circumstances of the procedure.The reported separation appears to be related to use error/operational context.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• 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: 14602140
• Report Number: 2024168-2022-05978
• Device Sequence Number: 20370091
• Product Code: LIT
• UDI-Device Identifier: 08717648154959
• UDI-Public: 08717648154959
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 08/17/2022

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 Expiration Date: 07/31/2025
• Device Model Number: B1100-060
• Device Catalogue Number: B1100-060
• Device Lot Number: 20216G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6FR SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 86 KG