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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 H7493918915150
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 11/03/2017
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr. , eval summary attached, method codes, result codes, conclusion codes updated. Device evaluated by mfr: returned product consisted of an emerge balloon catheter and a stopcock. The balloon was tightly folded with contrast in the inflation lumen. The tip, balloon, hypotube, inner and outer shafts were microscopically and tactile examined. Inspection revealed numerous kinks in the hypotube with a separation at 85. 5 cm from the tip of the device. The end of the separation was oval, as if kinked prior to separation. Inspection of the remainder of the device revealed no other damage or irregularities. The presence of contrast/fluid in the inflation, indicates use of the device beyond preparation. The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. Bsc id: (b)(4). Tw: 4875893.
 
Event Description
It was reported that shaft break occurred. During preparation of a 1. 50mm x 15mm emerge¿ balloon catheter, it was noted that the shaft was fractured. The procedure was completed with a different device. No patient complications were reported.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that shaft break occurred. During preparation of a 1. 50mm x 15mm emerge¿ balloon catheter, it was noted that the shaft was fractured. The procedure was completed with a different 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 Key7099913
MDR Text Key249021606
Report Number2134265-2017-11820
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121196
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2019
Device Model NumberH7493918915150
Device Catalogue Number39189-1515
Device Lot Number20139364
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/10/2017
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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