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

Model Number	7134
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
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 selected for use.However, during loading the balloon on the non-boston scientific (bsc) wire, the mid shaft of the stainless-steel rod was snapped in half.The device was pulled out from the wire, and the procedure was completed with non-bsc 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.
Additional Manufacturer Narrative
B3 - date of event: used the first day of the month of aware date, as event date was not provided.D4 - lot number: corrected from 0031578883 to 0031689256.Device evaluated by mfr: returned product consisted of an emerge mr balloon catheter.The device was visually and microscopically examined.There was a separation of the hypotube 59.5cm from the strain relief.There were numerous kinks to the hypotube.There were no fluids detected to the device and the balloon was tightly folded.
Event or Problem Description
It was reported that shaft break occurred.A 2.50mm x 20mm emerge balloon catheter was selected for use.However, during loading the balloon on the non-boston scientific (bsc) wire, the mid shaft of the stainless-steel rod was snapped in half.The device was pulled out from the wire, and the procedure was completed with non-bsc device.There were no patient complications reported.

• Brand Name: EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17696779
• Report Number: 2124215-2023-48617
• Device Sequence Number: 6246661
• Product Code: LOX
• UDI-Device Identifier: 08714729806325
• UDI-Public: 08714729806325
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/26/2023

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: 01/24/2026
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0031689256
• 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: 08/31/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2023
• 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