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

Model Number B1070-120

Device Problems Failure to Fold (1255); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)

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

Event Date 07/04/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 lesion located in the right common femoral artery and external iliac artery that was heavily calcified.It is possible that the the armada 35 balloon catheter contained a higher than optimal concentration of contrast.The balloon dilatation catheter was advanced to the lesion and on the first inflation at nominal, the balloon ruptured.The balloon would not re-wrap adequately and during removal, the balloon became stuck to the 6fr sheath and the distal end tore.Without further intervention, the torn end of the balloon was pulled into the dilator of the short (access) 6fr sheath as the wire was pulled back.The wire remained in the patient for further planned intervention.The sheath was replaced and further angioplasty and stenting occurred.There was no reported adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported balloon rupture, separation and loose refold were 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 identified no other similar incidents and/or complaints reported from this lot.As it was reported that it is possible that the armada 35 balloon catheter contained a higher than optimal concentration of contrast, it should be noted that the armada 35 instruction for use (ifu) indicates to use 60% contrast diluted 1:1 with normal saline.It could not be determined if using a higher than optimal concentration of contrast caused or contributed to the reported difficulties.The investigation determined that the reported difficulties were likely due to circumstances of the procedure.It is likely that the balloon rupture was the result of interaction with the heavily calcified anatomy.It is likely that the rupture initiated longitudinal.In addition, as a result of the rupture, it is likely that the balloon material was unable to refold optimally causing the material to become stuck with the 6fr sheath during removal and ultimately separate.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
• 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: 15099623
• MDR Text Key: 298463091
• Report Number: 2024168-2022-08149
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648154829
• UDI-Public: 08717648154829
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: B1070-120
• Device Catalogue Number: B1070-120
• Device Lot Number: 00615G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2020
• 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