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

Model Number	7139
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device break occurred.A 1.50mm x 20mm emerge balloon catheter was advanced for dilatation.However, during the procedure, the device was noted to be defective and broken.The device was pulled and removed intact from the patient's body.The procedure was completed with another of the same device and no patient complications were reported.
Event or Problem Description
It was reported that device break occurred.A 1.50mm x 20mm emerge balloon catheter was advanced for dilatation.However, during the procedure, the device was noted to be defective and broken.The device was pulled and removed intact from the patient's body.The procedure was completed with another of the same device and no patient complications were reported.
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 contrast in the inflation lumen and the balloon was tightly folded.Inspection of the device presented no damage or irregularities.Product analysis could not confirm the reported event as there was no damage or irregularity to the device.

• 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; 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: 18426088
• Report Number: 2124215-2023-74561
• Device Sequence Number: 8109270
• Product Code: LOX
• UDI-Device Identifier: 08714729806035
• UDI-Public: 08714729806035
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2024

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: 11/19/2025
• Device Model Number: 7139
• Device Catalogue Number: 7139
• Device Lot Number: 0031261446
• 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: 12/13/2023
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2023
• 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