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

Model Number	7132
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first day of the month of aware date, as event date was not provided.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left anterior descending artery.A 2.50mm x 12mm emerge balloon catheter was selected for use.However, during preparation, the balloon ruptured.The procedure was completed with a different device.There were no patient complications reported.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left anterior descending artery.A 2.50mm x 12mm emerge balloon catheter was selected for use.However, during preparation, the balloon ruptured.The procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
B3 date of event: used the first day of the month of aware date, as event date was not provided.Device evaluated by mfr.: returned product consisted of an incomplete device return of an emerge mr balloon catheter.The device was visually and microscopically examined.At 51.5cm 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 were numerous kinks to the hypotube.No further damage was found to the returned portion of the device which included the manifold, strain relief, and a portion of the hypotube.Product analysis could not confirm the reported burst as the balloon portion of the device failed to return for further analysis.

• Brand Name: EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15325514
• Report Number: 2124215-2022-31428
• Device Sequence Number: 20423397
• Product Code: LOX
• UDI-Device Identifier: 08714729806103
• UDI-Public: 08714729806103
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2022

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: 12/23/2024
• Device Model Number: 7132
• Device Catalogue Number: 7132
• Device Lot Number: 0029308166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown