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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN GUIDER/40DEG XF/7FR/90CM CATHETER, PERCUTANEOUS

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BOSTON SCIENTIFIC - MINN GUIDER/40DEG XF/7FR/90CM CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number H965100430
Device Problem Peeled/Delaminated (1454)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/18/2015
Event Type  Malfunction  
Manufacturer Narrative

The subject device is not available.

 
Event Description

It was reported that after the procedure, wear on the hydrophilic coating of the distal section of the guide catheter (subject device) was observed. "the first external coating of the catheter melted/dissolved and the part of metallic alloy was exteriorized. " no consequences to the patient were reported.

 
Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications. Analysis of the returned device revealed that the distal shaft outer layer had been dissolved along its length, exposing the shaft braid. No other anomalies were observed and the device was conforming to its required dimensional specifications. Information received indicated that no anomalies were noted to the device prior to use and the device was used according to the directions for use (dfu). Therefore the investigation concluded a definitive cause could not be determined and an assignable cause of undeterminable was assigned for the reported and observed issues.

 
Event Description

It was reported that after the procedure, wear on the hydrophilic coating of the distal section of the guide catheter (subject device) was observed. "the first external coating of the catheter melted/dissolved and the part of metallic alloy was exteriorized. " no consequences to the patient were reported.

 
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Brand NameGUIDER/40DEG XF/7FR/90CM
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MINN
one scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC - MINN
one scimed place
maple grove MN 55311
Manufacturer Contact
sanda dracic
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key5336586
MDR Text Key34746578
Report Number3008853977-2015-00546
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeBR
PMA/PMN NumberK980453
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/08/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/30/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/13/2016
Device Catalogue NumberH965100430
Device LOT Number15950148
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/04/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/26/2013
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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