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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 Problems Difficult to Advance (2920); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/22/2018
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an emerge balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the whole device.Microscopic examination revealed that the tip is damaged.There is a pinhole in the balloon 5mm from the tip.There is blood present in the guide wire lumen and balloon.The device was placed into a water bath to soften the dried blood in the device so a functional test could be performed.The guide wire used in the clinical procedure was not returned with the device so a test guide wire was used for functional testing.A.014 test guide wire was advanced into the guide wire lumen and was unable to pass the kinks in the guide wire lumen.Inspection of the remainder of the device presented no other damage or irregularities.
 
Event Description
Reportable based on device analysis completed on 07-jan-2019.It was reported that tip damage occurred and advancing difficulties were encountered.The 95% stenosed, 2.5x15mm was located in the severely tortuous and moderately calcified left anterior descending artery.A 2.00mm x 15mm emerge balloon catheter was advanced for dilatation.However, it was noted that the tip of the balloon was damaged and the device could not reach the lesion.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed a balloon pinhole.
 
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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 SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8283320
MDR Text Key134305003
Report Number2134265-2019-00483
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,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 01/28/2019
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 Date10/12/2020
Device Model Number7133
Device Catalogue Number7133
Device Lot Number0021753592
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/07/2019
Initial Date FDA Received01/28/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/15/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age51 YR
Patient Weight66
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