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

Catalog Number	B1140-040
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562); Component Missing (2306); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a lesion in the subclavian artery.The 14.0x40mm armada 35 balloon dilatation catheter (bdc) was prepared outside (air aspiration) outside the anatomy prior to use.The balloon was used for post-dilatation and had resistance with the anatomy during advancement.The balloon was inflated once at nominal pressure but ruptured.The bdc was removed without resistance, however, the balloon tore in half and separated when it was to the level of the sheath.There was no force applied.It was believed that there were no markers seen on the balloon to begin with and there were no markers on fluoroscopy floating in the anatomy.The tip of the guide wire was located instead and gained access in the left femoral vein through the iliac and up the aorta with a snared wire from below and through the femoral sheath, pushed the non-abbott catheter through the arm over the wire.The physician was able to remove one half of the balloon through the arm access site, and removed the tip of the balloon that was detached from the catheter through the femoral vein.Nothing remains in the anatomy.The patient received more radiation, more contrast, and had to have another access site.It took roughly 2 hours to retrieve the balloon also causing the need for more medication.There was no adverse patient sequelae.There was a significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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 identified no other similar incidents and/or complaints from this lot.The investigation determined the reported difficulty advancing the device, unexpected medical intervention and delay to treatment/therapy appear to be related to operational context.The investigation was unable to determine a conclusive cause for the reported balloon rupture, separation, and missing component.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the subclavian artery.The 14.0x40mm armada 35 balloon dilatation catheter (bdc) was prepared outside (air aspiration) outside the anatomy prior to use.The balloon was used for post-dilatation and had resistance with the anatomy during advancement.The balloon was inflated once at nominal pressure but ruptured.The bdc was removed without resistance, however, the balloon tore in half and separated when it was to the level of the sheath.There was no force applied.It was believed that there were no markers seen on the balloon to begin with and there were no markers on fluoroscopy floating in the anatomy.The tip of the guide wire was located instead and gained access in the left femoral vein through the iliac and up the aorta with a snared wire from below and through the femoral sheath, pushed the non-abbott catheter through the arm over the wire.The physician was able to remove one half of the balloon through the arm access site, and removed the tip of the balloon that was detached from the catheter through the femoral vein.Nothing remains in the anatomy.The patient received more radiation, more contrast, and had to have another access site.It took roughly 2 hours to retrieve the balloon also causing the need for more medication.There was no adverse patient sequelae.There was a significant delay in the procedure.Subsequent to the initially filed report, the following information was provided: it was noticed that there were no markers seen on the balloon at the end of the procedure.The physician was able to position the balloon using contrast and locate the stent for post-dilatation.No additional information was provided.

• 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: 17765242
• Report Number: 2024168-2023-10160
• Device Sequence Number: 6617844
• Product Code: LIT
• UDI-Device Identifier: 08717648155024
• UDI-Public: 08717648155024
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/06/2023

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: 09/30/2026
• Device Catalogue Number: B1140-040
• Device Lot Number: 30417G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2023
• 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: GLIDE CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown