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

Model Number 7132

Device Problems Break (1069); Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2021

Event Type  malfunction  

Event Description

It was reported that a shaft break occurred.A 2.00mm x 12mm emerge balloon catheter was selected for use.The emerge was advanced and crossing difficulties were encountered.During an unknown time in the procedure the emerge delivery system broke while inside the patient body.All the pieces were retrieved.No patient complications were reported.

• Brand Name: EMERGE
• Type of Device: 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: 13006603
• MDR Text Key: 282276902
• Report Number: 2134265-2021-15725
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729806080
• UDI-Public: 08714729806080
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/14/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2024
• Device Model Number: 7132
• Device Catalogue Number: 7132
• Device Lot Number: 0027645452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1