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

Model Number B1070-040

Device Problems Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2022

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a heavily calcified common iliac artery.During the first inflation of the 7.0x40mm armada 35 balloon dilatation catheter (bdc) the balloon ruptured at 8 atmospheres and the distal shaft separated.It was noted resistance with anatomy was felt during removal of the bdc.Open surgery was performed to retrieve the separation portion.There were no adverse patient sequela and no clinically significant delay reported.No additional information was provided.

Manufacturer Narrative

A visual inspection was performed on the returned device.The reported balloon rupture and separation were confirmed.The reported difficulty removing the device could not be replicated in a testing environment as it was based on operational circumstances.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, difficulty removing the device, separation, surgical procedure, hospitalization, and removal of foreign body appear to be related to circumstances of the procedure.There was no leak noted during preparation, which suggests a product quality issue did not contribute to the reported difficulties.Based on the reported information and analysis of the returned device, it is likely that the balloon rupture was the result of interaction with the heavily calcified lesion.In addition, the resistance noted during removal and radial separation of the balloon was likely the result of the ruptured balloon material catching on the challenging anatomy during removal.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
• Type of Device: 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: 14347544
• MDR Text Key: 291308241
• Report Number: 2024168-2022-05091
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648154782
• UDI-Public: 08717648154782
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B1070-040
• Device Catalogue Number: B1070-040
• Device Lot Number: 11119G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability; Required Intervention