MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATION CATHETER 3.25MM X 12 MM, 145 CM; PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER

Model Number REF 1012275-12

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 11/18/2019

Event Type  Injury  

Event Description

During ptca procedure of mid left circumflex artery the balloon fractured and became entrapped within calcified vessel.Balloon was unable to be retrieved so decision was made to abort and monitor pt closely in ccu.Pt experience no untoward symptoms during stay or up to this writing.Fda safety report id# (b)(4).

• Brand Name: TREK CORONARY DILATION CATHETER 3.25MM X 12 MM, 145 CM
• Type of Device: PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR ; santa clara CA 95054
• MDR Report Key: 9458553
• MDR Text Key: 170679256
• Report Number: MW5091602
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138492
• UDI-Public: (01)08717648138492
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: REF 1012275-12
• Device Catalogue Number: 1012275-12
• Device Lot Number: 90207G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 60 YR