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

Model Number 1012270-12

Device Problems Difficult to Remove (1528); Difficult to Advance (2920)

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

Event Date 08/02/2022

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The xience pros stent referenced in this report is filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat a distal left circumflex artery that was 99% stenosed.During the procedure, kissing balloon technique was used.A mini trek balloon was advanced first and then the xience pros stent and there was a lot of friction during advancement between the xience pros stent and mini trek balloon, however, it is unknown if the failure was due to the guide wire, mini trek balloon, or xience pros stent.It is unknown how the procedure was completed.The devices were removed but not separately.There was a delay in the procedure, however, there was no adverse patient effects to the patient due to the delay.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.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 incidents and/or complaints from this lot.The investigation determined the reported difficulty advancing and removing the devices appears to be related to circumstances of the procedure.It should be noted that the account was reportedly performing a kissing balloon technique (kbt), which narrows the access through the guiding catheter due to the multiple devices inserted at once.In this case, it is likely that the balloon dilatation catheter (bdc) and the stent delivery system (sds) interacted with each other during advancement and retraction due to the reduced clearance in the guiding catheter.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• 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: 15473003
• MDR Text Key: 305791659
• Report Number: 2024168-2022-09958
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138140
• UDI-Public: 08717648138140
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K103110
• 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: 10/13/2022

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 Model Number: 1012270-12
• Device Catalogue Number: 1012270-12
• Device Lot Number: 20411G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2022
• Initial Date FDA Received: 09/23/2022
• Supplement Dates Manufacturer Received: 10/12/2022
• Supplement Dates FDA Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2022
• 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: XIENCE PROS