Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC PROWLER SELECT MICROCATHETERS; CES MICROCATHETERS (KRA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CODMAN AND SHURTLEFF, INC PROWLER SELECT MICROCATHETERS; CES MICROCATHETERS (KRA) Back to Search Results
Catalog Number 606SXXX
Device Problem Obstruction of Flow (2423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/24/2015
Event Type  malfunction  
Event Description
The contact at the facility reported that the stent (enf452800/10414056) did not advance through the prowler select plus (details unknown).The physician used another same sized stent.The procedure was successfully done.At initial contact the product was available for return.
 
Manufacturer Narrative
Concomitant devices: enterprise stent (details unknown); enterprise stent (enf452800/10414056).The root cause of the issue cannot be determined because the product is not available for return.The lot number was not provided therefore a device history record review could not be performed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key4776125
MDR Text Key17579716
Report Number1058196-2015-00109
Device Sequence Number1
Product Code KRA
Combination Product (y/n)N
Reporter Country CodeKN
PMA/PMN Number
K021591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number606SXXX
Date Manufacturer Received04/15/2015
Is the Device Single Use? Yes
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
-
-