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

Model Number	7133
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The patient presented with coronary blockage.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified left anterior descending artery.A 2.00mm x 15mm emerge balloon catheter was advanced for dilation.The device came out completely without issue.However, after removing it from the body, the mid-point of the metal hypotube broke.The procedure was completed with 2.5 x 15 emerge balloon catheter.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an emerge mr balloon catheter.The device was visually and microscopically examined.There was a separation of the hypotube 56.8 cm from the strain relief.The separation indicates the device was likely kinked prior to separation as the ends was oval in shape.There were numerous kinks to the hypotube.There was contrast in the inflation lumen and the balloon.There was blood in the guidewire lumen and the balloon was loosely folded.Product analysis confirmed the reported break as there was separation to the device.
Event or Problem Description
It was reported that shaft break occurred.The patient presented with coronary blockage.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified left anterior descending artery.A 2.00mm x 15mm emerge balloon catheter was advanced for dilation.The device came out completely without issue.However, after removing it from the body, the mid-point of the metal hypotube broke.The procedure was completed with 2.5 x 15 emerge balloon catheter.No patient complications were 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; 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: 17172055
• Report Number: 2124215-2023-30555
• Device Sequence Number: 12551259
• Product Code: LOX
• UDI-Device Identifier: 08714729806196
• UDI-Public: 08714729806196
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/25/2023

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: 07/04/2025
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0030465060
• 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: 06/07/2023
• Supplement Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2022
• 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