MAUDE Adverse Event Report: ABBOTT VASCULAR MINI TREK CORONARY DILATATION CATHETER

Model Number 1012269-12

Device Problems Leak/Splash (1354); Insufficient Information (3190); Material Split, Cut or Torn (4008)

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

Event Date 04/21/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.There were no reported device issues however return analysis noted a torn guide wire exit notch and multiple bends throughout the hypotube.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 did not indicate a lot specific quality issue.It is possible that manipulation of the device during an attempt to retrieve the noted xience pro a stent implant which was returned mangled on the balloon catheter resulted in the noted torn guide wire exit notch and the noted multiple bends throughout the hypotube; however without any additional information available, a conclusive cause for the reported difficulties could not be determined.The investigation determined a conclusive cause for the reported/noted difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported during the procedure the indeflator would not maintain pressure more than 4 to 6 atmospheres and kept decreasing in pressure.This caused the unspecified xience pro stent delivery system to not inflate properly and the stent to fold up and become knotted.The entire system was pulled out to ensure the stent was not left behind in the body.There was no adverse patient effects and no clinically significant delay was reported.No additional information was provided.A 1.5x12mm mini trek balloon catheter was received into the return goods lab with the xience pro stent mangled on it which is in line with the initial information received stating "a stent (dislodged) in a patient's radial artery".There was no reported information on the mini trek; however, device analysis revealed a torn notch and a leak.Follow-up with the site was performed regarding the mini trek; however, no additional information was provided.

• Brand Name: MINI TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY 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: 12009611
• MDR Text Key: 263567924
• Report Number: 2024168-2021-05040
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138096
• UDI-Public: 08717648138096
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 1012269-12
• Device Catalogue Number: 1012269-12
• Device Lot Number: 00918G2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2020
• 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