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

Catalog Number B2050-040

Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)

Patient Problems Pain (1994); Embolism/Embolus (4438)

Event Date 02/13/2023

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a heavily calcified femoral artery.The 5x40mm armada 35 balloon dilatation catheter (bdc) was advanced to the lesion.The balloon was over inflated and then fully deflated.During removal, resistance was noted with the anatomy, extra force was used and the bdc separated into four parts.Only three parts were removed from the patient via snare.The patient experienced pain and it was noted that an embolism had occurred in one of the axis of the leg.The fourth piece was removed via surgery a few weeks later.There was no adverse patient sequela; however, clinically significant delay was noted during the procedure.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.B3: date of event estimated.

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.It was reported that the balloon was overinflated during the procedure.It should be noted that the percutaneous transluminal angioplasty catheter (pta), armada 35/ armada 35ll global, ce, instruction for use (ifu) states: ¿inflation in excess of the rated burst pressure may cause the balloon to rupture.Use of a pressure monitoring device is recommended.¿ the rated burst pressure for this device is 22 atmospheres as indicated on the product label.In this case since it is unknown to what atmosphere the balloon was overinflated, it is unknown if the ifu violation contributed to the reported complaint.The investigation determined the reported difficulty removing the device, balloon separation, delay to treatment/therapy, hospitalization or prolonged hospitalization, surgical intervention and unexpected medical intervention appear to be related to operational context.A conclusive cause for the reported patient effects of embolism and pain and the relationship to the device, if any, cannot be determined.The reported patient effects of embolism and pain are listed in the percutaneous transluminal angioplasty (pta) catheter, armada 35 / armada 35 ll, global ifu as known patient effects.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

Event Description

Subsequently, after the initial report was filed it was noted the fourth piece was removed via open surgery.No additional information was provided.

• 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: 17722858
• MDR Text Key: 323110946
• Report Number: 2024168-2023-09883
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648155178
• UDI-Public: 08717648155178
• 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: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B2050-040
• Device Lot Number: 20216G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• 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; Other; Required Intervention