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

Catalog Number 1013470-150

Device Problems Failure to Fold (1255); Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)

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

Event Date 08/14/2023

Event Type  malfunction  

Manufacturer Narrative

H6: medical device problem code 2017 clarifier- contrast incorrect.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was to treat a lesion in the superficial femoral artery (sfa) with heavy calcification.The 6.0x150mm armada balloon dilatation catheter (bdc) was inflated one time to 12 atmospheres and confirmed to be fully deflated before removal.However, during removal the bdc became stuck in the 6fr sheath and a portion of the bdc became separated.As the balloon was still on the guide wire, the entire bdc including the separated portion were removed with the guide wire and the sheath as a single unit.After removal, the balloon was noted to be halfway inside the sheath and bunched.It was further reported that the contrast ration used was 30/70.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.

Event Description

Additional information: the contrast ratio was 5ml of contrast diluted with 10ml of saline.No additional information was provided.

Manufacturer Narrative

Visual inspection was performed on the returned device.The reported failure to fold (bunched balloon) and separation were confirmed.The reported difficulty removing the device could not be replicated in a testing environment due to the condition of the returned device.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 contrast mix used in the procedure was 5ml of contrast diluted with 10ml of saline.It should be noted that the percutaneous transluminal angioplasty (pta) catheter, armada 18, ce instructions for use (ifu) specified that the contrast diluted 1:1 with normal saline.In this case, since the contrast ratio used was less than the required percentage it is unknown if the ifu violation caused or contributed to the reported complaint.The investigation was unable to determine a conclusive cause for the reported failure to fold (bunched balloon); however, the reported difficulty removing the device and separation appear to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• 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: 17686100
• MDR Text Key: 322674201
• Report Number: 2024168-2023-09630
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648208447
• UDI-Public: 08717648208447
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1013470-150
• Device Lot Number: 2102441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2022
• 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
• Treatment: 6 FR SLENDER SHEATH
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 112 KG