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

Model Number	7137
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.An unknown boston scientific (bsc) balloon catheter was used; however, the shaft was broke.The procedure was completed with a non-bsc device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
B3 date of event: used the first date of the month of the aware date as no event date was provided.
Additional Manufacturer Narrative
B3 date of event: used the first date of the month of the aware date as no event date was provided.D4 lot number: updated to 0030792385.
Event or Problem Description
It was reported that shaft break occurred.An unknown boston scientific (bsc) balloon catheter was used; however, the shaft was broke.The procedure was completed with a non-bsc device.There were no patient complications nor injuries reported.It was further reported that the device was a 1.50mm x 12mm emerge push balloon catheter.
Additional Manufacturer Narrative
Device evaluated by mfr.Returned product consisted of an emerge push balloon catheter.The device was visually and microscopically examined.There was a separation of the hypotube 20cm from the strain relief.There were numerous kinks to the hypotube.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded, and the tip of the device was damaged.Product analysis confirmed the reported break as there was separation to the device.B3 date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that shaft break occurred.An unknown boston scientific (bsc) balloon catheter was used; however, the shaft was broke.The procedure was completed with a non-bsc device.There were no patient complications nor injuries reported.It was further reported that the device was a 1.50mm x 12mm emerge push balloon catheter.

• Brand Name: EMERGE PUSH
• 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17026026
• Report Number: 2124215-2023-27188
• Device Sequence Number: 19818741
• Product Code: LOX
• UDI-Device Identifier: 08714729805991
• UDI-Public: 08714729805991
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K121196
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2023
• 2 Devices were Involved in the Event: 1 2

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: 09/06/2025
• Device Model Number: 7137
• Device Catalogue Number: 7137
• Device Lot Number: 0030792385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 06/06/2023; 07/27/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 06/18/2023; 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2023
• 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