MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number 1012278-12

Device Problems Entrapment of Device (1212); Material Separation (1562)

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

Event Date 09/30/2022

Event Type  Injury  

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.The investigation was unable to determine a conclusive cause for the reported separation or entrapment of device; however, the reported unexpected medical intervention appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.The nc trek device referenced is filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat a mid right coronary artery.For post-dilatation, a trek balloon was inserted and advanced to the lesion.Unspecified number of inflations were performed.During removal, some resistance with an unspecified source was met and the shaft separated, remaining in the anatomy.Another nc trek balloon was advanced in an attempt to retrieve the separated shaft of the first balloon.However, during attempted removal, the nc trek shaft also separated, although no resistance was met.A 3rd unspecified balloon was used and advanced past the two separated portions, inflated and pulled the separated shafts out of the patient anatomy.Nothing remains in the patient.The procedure concluded at this point.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.

• Brand Name: 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: 15591259
• MDR Text Key: 301625991
• Report Number: 2024168-2022-10584
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138706
• UDI-Public: 08717648138706
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103110
• 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
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012278-12
• Device Catalogue Number: 1012278-12
• Device Lot Number: 20429G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2022
• 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): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female