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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK MEDICAL INC ANGIOGRAPHIC AUROUS SIZING PIGTAIL NONBEACON CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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COOK MEDICAL INC ANGIOGRAPHIC AUROUS SIZING PIGTAIL NONBEACON CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number N5.0-35-100-P-10S-PIG-CSC-20
Device Problem Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/30/2016
Event Type  malfunction  
Event Description
Initial inspection of catheter it was in one piece.Use of it later on in the case a crack was discovered in the hub upon connection with the power injector.Manufacturer response for nonbeacon marking pigtail catheter, angiographic aurous sizing pig (per site reporter): acknowledgement letter sent to rad tech.
 
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Brand Name
ANGIOGRAPHIC AUROUS SIZING PIGTAIL NONBEACON CATHETER
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
COOK MEDICAL INC
750 daniels way
bloomington, IN 47404
MDR Report Key5705331
MDR Text Key46818442
Report Number5705331
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2016
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date05/04/2019
Device Model NumberN5.0-35-100-P-10S-PIG-CSC-20
Device Catalogue NumberG11916
Device Lot Number6911666
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/07/2016
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer06/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
YES, POWER INJECTOR TUBING
Patient Age45 YR
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