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

Model Number	7134
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon detachment occurred.A 2.50mm x 20mm emerge balloon catheter was selected for use; however, when the device was removed from the package, the balloon simply fell apart.No other information available.
Event or Problem Description
It was reported that balloon detachment occurred.A 2.50mm x 20mm emerge balloon catheter was selected for use; however, when the device was removed from the package, the balloon simply fell apart.No other information available.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an incomplete emerge mr balloon catheter.The device was visually and microscopically examined.There was a separation of the shaft at the proximal end of the rapid port exchange.The separated end appears jagged indicating force was applied to the device.The hypotube was returned in full and had no damage or irregularity.The portion of the device from the proximal end of the rapid port exchange to the tip end of the device aside from the hypotube failed to return for further analysis.Product analysis confirmed the reported event as there was a shaft separation to the device.

• 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: 18509284
• Report Number: 2124215-2023-74560
• Device Sequence Number: 20799449
• Product Code: LOX
• UDI-Device Identifier: 08714729806325
• UDI-Public: 08714729806325
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 02/21/2024

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: 01/08/2026
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0031578883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2023
• 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