MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number 1014254-060

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

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

Event Date 10/08/2021

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 an unknown lesion.A 3x60mm armada 18 percutaneous transluminal balloon dilatation catheter (bdc) reportedly had a ¿persistent air leak¿ in the balloon during preparation.Contrast was seen leaking through the balloon when they tried inflating the balloon in the patient.The armada bdc was removed without issue and another armada bdc was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual and functional analysis was performed on the returned device.The reported leak was not confirmed.After leaving the balloon catheter in the water bath overnight, the balloon held pressure with no leaks noted as reported.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 complaints reported from this lot.It was reported that after a leak was noted during preparation, the device was used, and contrast was seen leaking through the balloon when they tried inflating the balloon in the patient.It should be noted that the armada 18 instruction for use (ifu) states: ¿carefully inspect the catheter prior to use to verify that it has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.¿ in this case, the returned analysis was unable to confirm that the device leaked.The investigation was unable to confirm the reported leak.It may be possible that the inflation device was not properly connected to the sidearm or the incorrect device was returned; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat an unknown lesion.A 3x60mm armada 18 percutaneous transluminal balloon dilatation catheter (bdc) reportedly had a ¿persistent air leak¿ in the balloon during preparation.Contrast was seen leaking through the balloon when they tried inflating the balloon in the patient.The armada bdc was removed without issue and another armada bdc was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: ARMADA 18 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, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12739873
• MDR Text Key: 280082912
• Report Number: 2024168-2021-09874
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K151317
• 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: 12/14/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 1014254-060
• Device Lot Number: 1042341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/02/2021
• Supplement Dates Manufacturer Received: 12/11/2021
• Supplement Dates FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2021
• 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 Age: 62 YR
• Patient Sex: Male