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

Model Number	7143
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed, 1.5mm x 1.5mm target lesion was located in the moderately tortuous and mildly calcified left anterior descending artery.A 1.50mm x 15mm emerge balloon catheter was advanced to dilate the lesion.However, during the procedure, the balloon delivery shaft was fractured.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed, 1.5mm x 1.5mm target lesion was located in the moderately tortuous and mildly calcified left anterior descending artery.A 1.50mm x 15mm emerge balloon catheter was advanced to dilate the lesion.However, during the procedure, the balloon delivery shaft was fractured.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.It was further reported that the device was removed by snaring.
Additional Manufacturer Narrative
(a2) age at time of event: 18 years or older.Device evaluated by manufacturer: returned product consisted of an emerge otw balloon catheter.The device was visually and microscopically examined.There were numerous shaft kinks to the device.There was contrast in the inflation lumen and the balloon was tightly folded.
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed, 1.5mm x 1.5mm target lesion was located in the moderately tortuous and mildly calcified left anterior descending artery.A 1.50mm x 15mm emerge balloon catheter was advanced to dilate the lesion.However, during the procedure, the balloon delivery shaft was fractured.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.It was further reported that the device was removed by snaring.
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.B1: adverse event/product problem: updated from product problem to adverse event and product problem.B2: outcomes attib to adv event: updated to required intervention to prevent permanent impairment.H1: type of reportable event: updated from malfunction to serious injury.H6: impact codes (1): updated from no health consequences or impact to additional device required.

• 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: 15002837
• Report Number: 2134265-2022-07424
• Device Sequence Number: 11233054
• Product Code: LOX
• UDI-Device Identifier: 08714729806790
• UDI-Public: 08714729806790
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2022

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: 05/11/2023
• Device Model Number: 7143
• Device Catalogue Number: 7143
• Device Lot Number: 0027288496
• 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: 06/20/2022
• Supplement Date Received by Manufacturer: 07/15/2022; 09/06/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 07/27/2022; 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown