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

Model Number 7163

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 08/29/2022

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.The patient presented for angioplasty and stent implantation.A 2.00 x 15mm emerge balloon catheter was advanced for dilation.During the procedure the balloon kinked and broke.The procedure was completed with another of the same device.There were no patient complications reported.

Event Description

It was reported that shaft break occurred.The patient presented for angioplasty and stent implantation.A 2.00 x 15mm emerge balloon catheter was advanced for dilation.During the procedure the balloon kinked and broke.The procedure was completed with another of the same device.There were no patient complications reported.

Manufacturer Narrative

Returned product consisted of an emerge mr balloon catheter.The device was visually and microscopically examined.There were numerous bends and kinks to the hypotube and shaft of the device.There was contrast in the inflation lumen and the balloon was tightly folded.There was no break in the device.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15621001
• MDR Text Key: 306611114
• Report Number: 2124215-2022-40543
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7163
• Device Catalogue Number: 7163
• Device Lot Number: 0028764041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2022
• 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