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

Model Number	7132
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 3.00 x 16 synergy drug-eluting stent was selected for use.However, during unpacking, it was noticed that the stent struts appeared to be lifted and deformed.The device was replaced with another stent.A 3.00mm x 12mm emerge balloon catheter was selected for use.However, during preparation upon introduction, the balloon shaft broke.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 emerge mr balloon catheter.The device was visually and microscopically examined.There was a separation of the hypotube 20cm from the strain relief.The separated ends of the hypotube were ovaled in shape indicating the device was kinked prior to separation.There were numerous hypotube kinks to the device.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded, and the tip of the device was damaged.Product analysis confirmed the reported break as there was separation to the device.There were unreported damages such as hypotube kinks, and tip damage.The damages found to the device are consistent with what can occur during preparation, procedural use, or an interaction with patient anatomy.
Event or Problem Description
It was reported that shaft break occurred.A 3.00 x 16 synergy drug-eluting stent was selected for use.However, during unpacking, it was noticed that the stent struts appeared to be lifted and deformed.The device was replaced with another stent.A 3.00mm x 12mm emerge balloon catheter was selected for use.However, during preparation upon introduction, the balloon shaft broke.The procedure was completed with another of same device.No patient complications were reported.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12962238
• Report Number: 2134265-2021-15575
• Device Sequence Number: 1854687
• Product Code: LOX
• UDI-Device Identifier: 08714729806127
• UDI-Public: 08714729806127
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/13/2022

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: 04/15/2024
• Device Model Number: 7132
• Device Catalogue Number: 7132
• Device Lot Number: 0027866515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2021
• Supplement Date Received by Manufacturer: 12/30/2021
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• 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