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

Model Number 7134

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 08/17/2021

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.A 2.50mm x 20mm emerge balloon catheter was advanced for dilatation.However, during removal, the device broke inside the guide catheter.The device was removed broken in two pieces.The procedure was completed successfully and no patient complications were reported.

Event Description

It was reported that shaft break occurred.A 2.50mm x 20mm emerge balloon catheter was advanced for dilatation.However, during removal, the device broke inside the guide catheter.The device was removed broken in two pieces.The procedure was completed successfully and no patient complications were reported.It was further reported that the target lesion was 80% stenosed and mildly tortuous.The balloon did not enter the patient's body and it appeared to be kinked right out of the hoop.When the balloon was loaded on the guidewire, the hypotube broke about 90cm from the distal tip.The procedure was completed with another emerge balloon of the ase size.

Manufacturer Narrative

Returned product consisted of an emerge mr balloon catheter.The device was visually and microscopically examined.The device has numerous kinks.There was a hypotube separation 59.9cm from the strain relief.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded, and there was blood and contrast present in the folds.

Event Description

It was reported that shaft break occurred.A 2.50mm x 20mm emerge balloon catheter was advanced for dilatation.However, during removal, the device broke inside the guide catheter.The device was removed broken in two pieces.The procedure was completed successfully and no patient complications were reported.It was further reported that the target lesion was 80% stenosed and mildly tortuous.The balloon did not enter the patient's body and it appeared to be kinked right out of the hoop.When the balloon was loaded on the guidewire, the hypotube broke about 90cm from the distal tip.The procedure was completed with another emerge balloon of the ase size.

• 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: 12367445
• MDR Text Key: 268137216
• Report Number: 2134265-2021-10767
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729806325
• UDI-Public: 08714729806325
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2024
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0027575739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1