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

Model Number	7132
Medical Device Problem Codes	Failure to Advance (2524); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon detachment occurred requiring additional intervention.The target lesion was located in the tortuous artery.A 2.00mm x 12mm emerge balloon catheter was advanced for dilatation.During the procedure, the balloon failed to pass the second lesion.It was noted that the balloon became stuck with the previously implanted stent and a piece tore off the end when trying to remove the balloon.Most of the balloon and wire were removed by pulling them out and the remaining piece of balloon was removed with a snare.There were no patient complications reported.
Event or Problem Description
It was reported that balloon detachment occurred requiring additional intervention.The target lesion was located in the tortuous artery.A 2.00mm x 12mm emerge balloon catheter was advanced for dilatation.During the procedure, the balloon failed to pass the second lesion.It was noted that the balloon became stuck with the previously implanted stent and a piece tore off the end when trying to remove the balloon.Most of the balloon and wire were removed by pulling them out and the remaining piece of balloon was removed with a snare.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a emerge mr balloon catheter.The device was visually and microscopically examined.There were numerous kinks to the hypotube and shaft of the device.There was blood in the hub, inflation lumen, and balloon.At 118cm from the strain relief, the shaft (inflation lumen) was separated and is the total length of the returned proximal end of the device.The proximal end of the device return consisted of the hypotube, manifold, and a portion of the inflation lumen.The distal segment returned with a total length of 2cm, which included the tip, guidewire lumen, the distal markerband, and a portion of the balloon and guidewire lumen.There was severe tip damage to the device.Product analysis confirmed the reported events as there was a shaft separation, severe tip damage, hypotube and shaft kinks, and an incomplete device return.

• 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: 17280515
• Report Number: 2124215-2023-34491
• Device Sequence Number: 17439169
• Product Code: LOX
• UDI-Device Identifier: 08714729806080
• UDI-Public: 08714729806080
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/12/2025
• Device Model Number: 7132
• Device Catalogue Number: 7132
• Device Lot Number: 0031023273
• 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: 06/14/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown