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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC PROWLER SELECT MICROCATHETERS; CES MICROCATHETERS (KRA)
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CODMAN AND SHURTLEFF, INC PROWLER SELECT MICROCATHETERS; CES MICROCATHETERS (KRA) Back to Search Results
Model Number 606S255X
Device Problem Obstruction of Flow (2423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/26/2014
Event Type  malfunction  
Event Description
During the procedure, the enterprise stent (enf452800lot /unk) had a lot of friction at proximal portion of the prowler select plus catheter (606s255x/16035926) and additional forced was used, and the stent appeared to detach in catheter.The system was removed and a new prowler select plus and stent was used and all went fine.Catheter was flushed on back table and stent was pushed out of catheter-all components are being returned.No damages were noticed on delivery or introducer, and the device was loaded in y connector.The device was completely seated in microcatheter hub, and no additional torque was used.However, resistant occurred right at the beginning of advancing system into prowler although a saline drip was used.No damages were noticed when opening package, and the enterprise was used per label for use.No shaping was done, and the procedure was completed with another exact size enterprise stent with no difficulties.There was no adverse event reported and the components will be returned for analysis.
 
Manufacturer Narrative
The product will be return for analysis, but it has not been received.Additional information will be submitted within 30 days of receipt.Also, please note that this is one of two devices reported under complaint (b)(4).
 
Manufacturer Narrative
During the procedure, the enterprise stent (enf452800lot /unk) had a lot of friction at proximal portion of the prowler select plus catheter (606s255x/16035926) and additional forced was used, and the stent appeared to detach in catheter.The system was removed and a new prowler select plus and stent was used and all went fine.Catheter was flushed on back table and stent was pushed out of catheter-all components were being returned, but to date no devices were received.No damages were noticed on delivery or introducer, and the device was loaded in y connector.The device was completely seated in microcatheter hub, and no additional torque was used.However, resistant occurred right at the beginning of advancing system into prowler although a saline drip was used.No damages were noticed when opening package, and the enterprise was used per label for use.No shaping was done, and the procedure was completed with another exact size enterprise stent with no difficulties.There was no adverse event reported and the components were not returned for analysis.The device was not returned for analysis.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.No lot number was provided for the enterprise vrd, therefore no review could be conducted.Without the devices the reported event could not be confirmed.However, based on the information it is possible that procedural factors may have contributed to the event.Additional, there was no defect noted with review of manufacturing records, therefore no corrective actions will be taking at this time.This report is for two devices reported under complaint number (b)(4).
 
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Brand Name
PROWLER SELECT MICROCATHETERS
Type of Device
CES MICROCATHETERS (KRA)
Manufacturer (Section D)
CODMAN AND SHURTLEFF, INC
325 paramount dr
raynham MA
Manufacturer Contact
duane durbin
14700 nw 57th court
miami lakes, FL 33014
5088288310
MDR Report Key4202593
MDR Text Key4964132
Report Number1058196-2014-00270
Device Sequence Number1
Product Code KRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,User Facility
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 10/06/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2016
Device Model Number606S255X
Device Catalogue Number606S255X
Device Lot Number16035926
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/05/2014
Date Device Manufactured01/06/2014
Type of Device Usage Initial
Patient Sequence Number1
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