MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number 1012274-08

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/12/2020

Event Type  Injury  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a lesion with heavy tortuosity in the circumflex artery.A 3.0 x 8 mm trek rx balloon dilatation catheter (bdc) was advanced without resistance and used for post stent dilatation.The bdc was then removed without any resistance; however, it was observed that the radiopaque balloon marker had come off the bdc and became stuck on the implanted stent.The balloon marker was not retrieved from the patient's anatomy.No delay in the procedure was reported.No additional information was provided.

Event Description

Subsequent to the initial filed report, follow up was performed and it was confirmed that a balloon rupture was not noted during the procedure.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 from this lot.As the balloon markers are attached to the inner member which is inside of the balloon it would not be possible for a balloon marker inside of a inflated balloon to come off of the inner member and attach to the previously deployed stent.Possibly, the physician inadvertently observed part of the previously deployed stent as a balloon marker resulting in the reported foreign body in patient; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11067478
• MDR Text Key: 223592995
• Report Number: 2024168-2020-10916
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138416
• UDI-Public: 08717648138416
• Combination Product (y/n): N
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 1012274-08
• Device Catalogue Number: 1012274-08
• Device Lot Number: 90828G1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 79