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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7133
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/25/2020
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr. : returned product consisted of an emerge balloon catheter in two pieces. Analysis of the tip, balloon, inner/outer shaft and hypotube included microscopic and visual inspection. Inspection revealed a shaft separation (fracture) in the hypotube located 67. 3 cm from the tip of the device, and numerous kinks in the hypotube. The fracture faces were ovalized, suggesting the fractured area was kinked prior to becoming separated. Inspection of the rest of the device found no other damage or defect.
 
Event Description
Reportable based on device analysis completed on 20jan2021. It was reported that shaft kink occurred. The 70% stenosed target lesion was located in mildly tortuous and moderately calcified left anterior descending artery. A 2. 00mm x 15mm emerge balloon catheter was advanced for dilatation. However, during procedure the device was kinked. The device was completely removed from the patient's body and the procedure was completed with another of same device. There were no patient complications reported and the patient status was stable. However, returned device analysis revealed shaft detached/separated.
 
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Brand NameEMERGE
Type of DeviceCATHETERS, 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 Key11294117
MDR Text Key230745016
Report Number2134265-2021-01393
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K113220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 02/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7133
Device Catalogue Number7133
Device Lot Number0025467923
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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