MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number 1012280-12

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/15/2020

Event Type  Injury  

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 from this lot.It is possible that interaction with the guide liner and/or other devices resulted in compromising the inflation/deflation lumen thus resulting in the reported deflation problem and difficult to remove; however this cannot be confirmed.Manipulation of the device in attempts to remove resulted in the reported material separation.As reported, all parts of the separated device were removed, except for the balloon portion with the markers.The separated inflated balloon with markers was left in the aneurysm that was going to be occluded.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that during an aneurysm repair procedure, the trek rx was advanced and inflated.A guide liner was advanced over the balloon.Attempts were made to deflate the balloon, but it failed to deflate.Some trouble shooting was performed, but the balloon still could not be deflated.During removal of the inflated balloon, it was pulled into the guide catheter, but broke mid-shaft.The separated portion was snared and pulled into the guide catheter, but the shaft broke again.All parts of the separated device were removed, except for the balloon portion with the markers.After a surgical consult the separated inflated balloon with markers was left in the aneurysm that was going to be occluded.The patient remained stable and remained hospitalized for another day for monitoring.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: 10627330
• MDR Text Key: 209806429
• Report Number: 2024168-2020-08254
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138775
• UDI-Public: 08717648138775
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 1012280-12
• Device Catalogue Number: 1012280-12
• Device Lot Number: 91018G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 70