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

Model Number	7134
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
Type of Reportable Event	Malfunction
Event or Problem 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12367445
• Report Number: 2134265-2021-10767
• Device Sequence Number: 4333227
• Product Code: LOX
• UDI-Device Identifier: 08714729806325
• UDI-Public: 08714729806325
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K113220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 08/27/2021; 09/23/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 08/31/2021; 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1