MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 7133

Device Problems Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2019

Event Type  malfunction  

Event Description

Reportable based on additional information received on 17apr2019.It was reported that tracking difficulties were encountered and shaft kink occurred.The 95% stenosed target lesion was located in the left anterior descending artery.Two 3.5mm x 15mm quantum maverick balloon catheters and two 2.00mm x 15mm emerge balloon catheters were advanced and used during this procedure.However, the balloons were entangled with the guidewire and the delivery shafts were kinked.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, additional information was received that the balloons were entrapped on the guide wire and became stuck together.Finally, the devices were removed successfully.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was blood in the inflation lumen and balloon.The balloon was loosely folded.There was a kink in the shaft 117.8cm distal from the strain relief.Microscopic inspection revealed tip damage.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.A pinhole leak was detected near the distal marker band.The marker band was inspected, and no damage was found.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

Reportable based on additional information received on 17apr2019.It was reported that tracking difficulties were encountered and shaft kink occurred.The 95% stenosed target lesion was located in the left anterior descending artery.Two 3.5mm x 15mm quantum maverick balloon catheters and two 2.00mm x 15mm emerge balloon catheters were advanced and used during this procedure.However, the balloons were entangled with the guidewire and the delivery shafts were kinked.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, additional information was received that the balloons were entrapped on the guide wire and became stuck together.Finally, the devices were removed successfully.

• Brand Name: EMERGE
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8603601
• MDR Text Key: 144824626
• Report Number: 2134265-2019-05167
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729806196
• UDI-Public: 08714729806196
• Combination Product (y/n): N
• PMA/PMN Number: K113220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/26/2020
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0022063619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Date Manufacturer Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 55