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

Model Number	7132
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the tortuous and heavily calcified middle of left anterior descending artery.A 2.50mm x 12mm emerge balloon catheter was advanced for dilatation.However, resistance was noticed during delivery of the device, and the shaft of the balloon fractured.The device was removed with the catheter as one unit.The procedure was completed with no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an incomplete emerge mr balloon catheter.The device was visually and microscopically examined.The total returned portion of the device was 62.6cm of which a portion of the hypotube, the strain relief and hub of the device failed to return.The hypotube was separated at the most proximal end of the returned portion.There were numerous kinks to the hypotube of the device.There was blood within the guidewire lumen and the balloon folds.The balloon was tightly folded.Product analysis confirmed the reported separation as there was a hypotube separation to the device.Product analysis could not confirm the reported difficulty to advance, as the clinical circumstances could not be replicated; however, there were numerous kinks to the hypotube of the device.
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the tortuous and heavily calcified middle of left anterior descending artery.A 2.50mm x 12mm emerge balloon catheter was advanced for dilatation.However, resistance was noticed during delivery of the device, and the shaft of the balloon fractured.The device was removed with the catheter as one unit.The procedure was completed with no patient complications nor injuries 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17232308
• Report Number: 2124215-2023-34043
• Device Sequence Number: 12537089
• Product Code: LOX
• UDI-Device Identifier: 08714729806103
• UDI-Public: 08714729806103
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2023

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: 11/12/2025
• Device Model Number: 7132
• Device Catalogue Number: 7132
• Device Lot Number: 0031221986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2023
• 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