MAUDE Adverse Event Report: ABBOTT VASCULAR INC. TREK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 1012276-25

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/30/2018

Event Type  Injury  

Event Description

The catheter shaft became detached from the balloon, leaving the balloon inflated inside the right coronary artery.Additional intervention required to remove balloon.No further intervention was required for this patient.The balloon was able to be retrieved from the coronary artery after manipulation only: the balloon was able to be manipulated and pulled back into the guide catheter.However, it was not able to be removed from the guide catheter so the guide wire, guide catheter and balloon all needed to be removed from the patient as a complete unit.Calcification/plaque was present: it was a calcified lesion that the md had used an atherectomy device on prior to ballooning and stenting.Ninety (90%) occlusion of the vessel.Manufacturer response for abbott vascular, trek rx 3.50mm x25mm (per site reporter): pending.

Event Description

The catheter shaft became detached from the balloon, leaving the balloon inflated inside the right coronary artery.Additional intervention required to remove balloon.No further intervention was required for this patient.The balloon was able to be retrieved from the coronary artery after manipulation only: the balloon was able to be manipulated and pulled back into the guide catheter.However, it was not able to be removed from the guide catheter so the guide wire, guide catheter and balloon all needed to be removed from the patient as a complete unit.Calcification/plaque was present: it was a calcified lesion that the md had used an atherectomy device on prior to ballooning and stenting.90% occlusion of the vessel.Manufacturer response for abbott vascular, trek rx 3.50mm x25mm (per site reporter) : pending.

• Brand Name: TREK
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• MDR Report Key: 7632320
• MDR Text Key: 112217532
• Report Number: 7632320
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012276-25
• Device Catalogue Number: 1012276-25
• Device Lot Number: 60624G1-3274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 185