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

Model Number	B2060-150
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The ht command guide wire, armada catheter and supera stent delivery system are being filed under separate medwatch report numbers.
Event or Problem Description
It was reported that on (b)(6) 2021, the patient presented with monckeberg sclerosis in the aorta with runoff in peripheral vessels and heavy calcification.That day, a percutaneous intervention was performed on the right popliteal and right superficial femoral artery (sfa) containing this heavy/jagged calcification.Using a 6 french sheath, an ht command guide wire advanced through the acute/steep iliac bifurcation without issues.Following, an armada 18 and an armada 35 balloon dilatation catheter had advanced without issues.Upon first inflation attempt, both balloons had ruptured below rated burst pressure due to the heavy, jagged calcification.The catheters were removed without issue and another device was used in replacement.The first supera stent was successfully implanted.Following, a second supera stent delivery advanced with difficulty/resistance noted with the command wire, once at the steep bifurcation.The supera had then become stuck on the wire and was unable to advance or be removed.Both were removed as a single unit (the wire and supera sds).Another device was used in replacement, completing the procedure, without further issues noted.There were no adverse patient effects and there was no clinically significant delay.No additional information was provided regarding this issue.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported material rupture was confirmed.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 revealed no other incidents and/or complaints reported from this lot.The investigation determined that the reported material rupture was likely due to case related circumstances.It is likely that the material rupture occurred due to interaction with the heavy lesion calcification.There is no indication of a product quality issue with respect to the 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: 13019434
• Report Number: 2024168-2021-11681
• Device Sequence Number: 4963477
• Product Code: LIT
• UDI-Device Identifier: 08717648155314
• UDI-Public: 08717648155314
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 01/28/2022

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: 04/30/2024
• Device Model Number: B2060-150
• Device Catalogue Number: B2060-150
• Device Lot Number: 01113G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2020
• 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: HT COMMAND GUIDE WIRE
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 46 KG