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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 H7493919312250
Device Problems Deflation Problem (1149); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 04/30/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that balloon deflation failure occurred. During preparation of a 2. 50mm x 12mm emerge¿ balloon catheter, the balloon failed to deflate after three attempts. The device was removed from the sterile scrub trolley and double bagged. The device was not used inside the patient and the procedure was completed with another of the same device. No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr. : returned product consisted of an emerge balloon catheter. The balloon was loosely folded. The outer shaft, inner shaft, balloon and tip were microscopically examined. There are numerous hypotube and shaft kinks. Functional testing using an inflation device was used to inflate the balloon. The balloon inflated quickly, the device held pressure and was deflated within specification. There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported difficulty. The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event. (b)(4).
 
Event Description
It was reported that balloon deflation failure occurred. During preparation of a 2. 50mm x 12mm emerge balloon catheter, the balloon failed to deflate after three attempts. The device was removed from the sterile scrub trolley and double bagged. The device was not used inside the patient and the procedure was completed with another of the same device. No patient complications were reported.
 
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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 Key7546327
MDR Text Key109316532
Report Number2134265-2018-04808
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K113220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/23/2020
Device Model NumberH7493919312250
Device Catalogue Number39193-1225
Device Lot Number21789449
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/26/2018
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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