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

Model Number 24707

Device Problems Break (1069); Difficult to Remove (1528); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter facility name: (b)(6) hospital.

Event Description

It was reported that the catheter was difficult to remove and broke.The 99% stenosed, target lesion was located in the moderately tortuous and severely calcified below the knee artery.A 1.2mmx15mmx142cm balloon catheter was advanced.However, during advancing the balloon, the shaft got kinked.Upon removal, the device was difficult to remove and a break occurred.The physician removed the device with force and the procedure was completed with a different device.There were no patient complications nor injuries reported.

Manufacturer Narrative

E1 - initial reporter facility name: (b)(6) hospital.Device evalauted by mfr: returned product consisted of a coyote fc balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the hypotube and shaft.The inflation lumen is separated 24.8cm from the tip.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that the catheter was difficult to remove and broke.The 99% stenosed, target lesion was located in the moderately tortuous and severely calcified below the knee artery.A 1.2mmx15mmx142cm balloon catheter was advanced.However, during advancing the balloon, the shaft got kinked.Upon removal, the device was difficult to remove and a break occurred.The physician removed the device with force and the procedure was completed with a different device.There were no patient complications nor injuries reported.

• 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: 12067917
• MDR Text Key: 258369130
• Report Number: 2134265-2021-08159
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• 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: 07/18/2021

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 Expiration Date: 01/04/2023
• Device Model Number: 24707
• Device Catalogue Number: 24707
• Device Lot Number: 0026572949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Initial Date Manufacturer Received: 06/03/2021
• Initial Date FDA Received: 06/25/2021
• Supplement Dates Manufacturer Received: 07/01/2021
• Supplement Dates FDA Received: 07/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER: GUIDELINERPV; GUIDE CATHETER: GUIDELINERPV; GUIDEWIRE: CRUISE; GUIDEWIRE: CRUISE; INTRODUCER SHEATH: PARENT 6F; INTRODUCER SHEATH: PARENT 6F; GUIDE CATHETER: GUIDELINERPV; GUIDEWIRE: CRUISE; INTRODUCER SHEATH: PARENT 6F
• Patient Outcome(s): Required Intervention