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

Model Number	7133
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the left anterior descending artery.Two 3.50mm x 15mm emerge balloon catheter was advanced for dilatation.However, during the procedure, the shaft broke.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the left anterior descending artery.A 3.50mm x 15mm emerge balloon catheter was advanced for dilatation.However, during the procedure, the shaft broke.The procedure was completed with a different device.No patient complications were reported.It was further reported that the shaft broke on only one emerge balloon catheter.The emerge balloon catheter was pulled back into the guide catheter and was removed.The patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an incomplete device return of an emerge mr balloon catheter.The device was microscopically and visually examined.At 75.9cm from the strain relief the hypotube was separated, which was also the length of the device returned.The separated end was ovaled in shape indicating the device was kinked prior to separation.There was blood present in the manifold.No further damages were found.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the left anterior descending artery.Two 3.50mm x 15mm emerge balloon catheter was advanced for dilatation.However, during the procedure, the shaft broke.The procedure was completed with a different device.No patient complications were reported.It was further reported that the shaft broke on only one emerge balloon catheter.The emerge balloon catheter was pulled back into the guide catheter and was removed.The patient status was stable.

• 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: 12136081
• Report Number: 2134265-2021-08710
• Device Sequence Number: 17156795
• Product Code: LOX
• UDI-Device Identifier: 08714729806257
• UDI-Public: 08714729806257
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2021

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: 09/04/2023
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0026594202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 07/16/2021; 08/17/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 07/23/2021; 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR