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

Model Number	7134
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The patient presented with coronary artery disease (cad) and underwent percutaneous coronary intervention (pci).The 95% stenosed target lesion was located in the non-tortuous and non-calcified mid left anterior descending (lad) artery.A 2.50mm x 20mm emerge balloon catheter was selected for use; however, the shaft broke at the transition of the hypotube to the balloon upon removal from the hoop.The procedure was completed with another of same device.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.The patient presented with coronary artery disease (cad) and underwent percutaneous coronary intervention (pci).The 95% stenosed target lesion was located in the non-tortuous and non-calcified mid left anterior descending (lad) artery.A 2.50mm x 20mm emerge balloon catheter was selected for use; however, the shaft broke at the transition of the hypotube to the balloon upon removal from the hoop.The procedure was completed with another of same device.No patient complications were 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 manifold of the device failed to return for further analysis.The total length of the device returned was 98.3cm.There was a separation of the hypotube at the strain relief.The separated end was ovaled in shape indicating the device was kinked prior to separation.There were numerous bends and kinks to the hypotube.There was contrast in the inflation lumen, and the balloon was loosely folded.Product analysis confirmed the reported break as there was separation to the device.

• Brand Name: EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15379156
• Report Number: 2124215-2022-33555
• Device Sequence Number: 14829315
• Product Code: LOX
• UDI-Device Identifier: 08714729806325
• UDI-Public: 08714729806325
• 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): 10/14/2022

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: 11/23/2024
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0029132028
• 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: 08/25/2022
• Supplement Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2022
• 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 Age: 73 YR
• Patient Sex: Female
• Patient Weight: 102 KG
• Patient Race: White