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

Model Number 1012278-15

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/25/2017

Event Type  malfunction  

Event Description

Doctor went up with the balloon and prior to inflation, the end of the balloon and the catheter broke off and was free inside the patient.The free floating piece was successfully, entirely snared, and removed from the patient without further incident.The scheduled procedure continued without incident.

• Brand Name: TREK
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 26531 ynez rd.; temecula CA 92591
• MDR Report Key: 6770296
• MDR Text Key: 81926698
• Report Number: 6770296
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1012278-15
• Device Catalogue Number: 1012278-15
• Device Lot Number: 510009G1
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2017
• Event Location: Other
• Date Report to Manufacturer: 08/02/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/07/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR