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

Catalog Number	B2060-080
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a lesion in the mid right superficial femoral artery (sfa) with 80-90% stenosis, moderate calcification and no tortuosity.The 6.0x80mm armada 35 balloon dilatation catheter (bdc) was advanced without resistance but ruptured during the first inflation at rated burst pressure (rbp).Attempted to remove the balloon through the sheath but would not pass through the sheath.The sheath was removed from the patient's groin and the balloon had to be cut off of the bdc so the balloon catheter could be pulled out of the sheath.The sheath was then put back in the patient's groin and the procedure continued.Nothing remains in the patient and every piece of the armada bdc was removed.Another bdc was used to complete the procedure.There was no adverse patient effect and there was no clinically 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
Visual analysis was performed on the returned device.The reported balloon rupture was confirmed.The reported difficulty to remove could not be replicated in a testing environment due to the condition of the returned device.The electronic lot history record (elhr) and corrective and preventive 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 no other similar complaints from this lot.The investigation determined the reported balloon rupture and difficulty removing the device appear to be related to operational context.There was no leak noted during preparation, 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 moderately calcified anatomy such that the balloon became damaged and ruptured during inflation.Additionally, the resistance reported during removal likely result from the ruptured balloon material catching on the introducer sheath during removal as the rupture likely did not allow the balloon material to refold properly.Based on the reported information, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the mid right superficial femoral artery (sfa) with 80-90% stenosis, moderate calcification and no tortuosity.The 6.0x80mm armada 35 balloon dilatation catheter (bdc) was advanced without resistance but ruptured during the first inflation at rated burst pressure (rbp).Attempted to remove the balloon through the sheath but would not pass through the sheath.The sheath was removed from the patient's groin and the balloon had to be cut off of the bdc so the balloon catheter could be pulled out of the sheath.The sheath was then put back in the patient's groin and the procedure continued.Nothing remains in the patient and every piece of the armada bdc was removed.Another bdc was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in 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: 18798756
• Report Number: 2024168-2024-02493
• Device Sequence Number: 17936611
• Product Code: LIT
• UDI-Device Identifier: 08717648155284
• UDI-Public: (01)08717648155284(17)251031(10)20513G1
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 04/24/2024

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: 10/31/2025
• Device Catalogue Number: B2060-080
• Device Lot Number: 20513G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2022
• 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
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 80 KG