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

Model Number	B1080-020
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified mid superficial femoral artery in the left leg.A non-abbott stent was implanted.During post-dilatation of a 8x20mm armada 35 balloon burst at 8 atmospheres.Then a 5x40mm armada 35 balloons burst at 26 atmospheres.The balloons were at the proximal end of the stent (2/3 outside the stent and to 1/3 in the stent) - when it burst.There was no damage to the patient.The balloons were successfully removed.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional armada 35 balloon is filed under a separate medwatch report number.
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 balloon rupture appears to be related to operational context.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 rupture occurred due to interaction with the heavily calcified anatomy and the previously implanted stent.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified mid superficial femoral artery in the left leg.A non-abbott stent was implanted.During post-dilatation of a 8x20mm armada 35 balloon burst at 8 atmospheres.Then a 5x40mm armada 35 balloons burst at 26 atmospheres.The balloons were at the proximal end of the stent (2/3 outside the stent and to 1/3 in the stent) - when it burst.There was no damage to the patient.The balloons were successfully removed.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to the initially filed mdr report, the account provided additional information: during post-dilatation of a 8x20mm armada 35 balloon, it was inflated twice at nominal pressure and then burst at 8 atmospheres.Then a 5x40mm armada 35 balloon was inflated twice at nominal pressure and then burst at 26 atmospheres.Another unspecified balloon was used to successfully complete the procedure.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: 14946704
• Report Number: 2024168-2022-07306
• Device Sequence Number: 17334287
• Product Code: LIT
• UDI-Device Identifier: 08717648154850
• UDI-Public: 08717648154850
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: B1080-020
• Device Catalogue Number: B1080-020
• Device Lot Number: 91024G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2019
• 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
• Patient Sex: Unknown