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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493918908200
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 05/20/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Device evaluated by mfr. : the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental med watch will be filed. (b)(4).
 
Event Description
It was reported that shaft break occurred. During preparation of a 2. 00mm x 8mm emerge¿ balloon catheter, the shaft of the catheter snapped while the device was being removed from the ring. The device never entered the patient's body and the procedure was completed with a different device. No patient complications were reported and the patient's status was stable.
 
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Brand NameEMERGE¿
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6618953
MDR Text Key76878582
Report Number2134265-2017-05774
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 05/22/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/17/2019
Device Model NumberH7493918908200
Device Catalogue Number39189-0820
Device Lot Number20552996
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/22/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/25/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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