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

Model Number	7132
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 2.50mm x 12mm emerge balloon catheter was advanced for dilatation.However, while inserting prior to cross the lesion, the balloon was noted to be broken the device was removed without issue and the procedure was completed with a new 2.5x12mm emerge balloon catheter.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an emerge mr balloon catheter.Photo media was attached in complaint record.The device was visually and microscopically examined.At 56cm, and 58cm from the strain relief, the hypotube was kinked.There was a separation of the hypotube 59.4cm from the strain relief.The separated ends were ovaled in shape indicating the device was kinked prior to separation.At 5cm distal form the separation, there was a kink in the hypotube.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.Photo media depicted the sizing on the hub, and blood to the device.There was a hypotube separation near the middle of the device and three hypotube kinks within proximity to the hypotube separation.Media review aligns with what was seen in analysis and confirmed the reported event.Product analysis confirmed the reported break as there was separation to the device.
Event or Problem Description
It was reported that shaft break occurred.A 2.50mm x 12mm emerge balloon catheter was advanced for dilatation.However, while inserting prior to cross the lesion, the balloon was noted to be broken the device was removed without issue and the procedure was completed with a new 2.5x12mm emerge balloon catheter.There were no patient complications reported.

• 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: 15255016
• Report Number: 2124215-2022-29110
• Device Sequence Number: 5787768
• Product Code: LOX
• UDI-Device Identifier: 08714729806103
• UDI-Public: 08714729806103
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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: 0029304230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 08/18/2022
• 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 Age: 83 YR
• Patient Sex: Male