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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL, INC. TD TORQUE LINE CATHETER
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ICU MEDICAL, INC. TD TORQUE LINE CATHETER Back to Search Results
Model Number 41239-06
Device Problems Detachment Of Device Component (1104); Defective Component (2292)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/01/2014
Event Type  malfunction  
Event Description
Complaint received reporting catheter component (balloon) issues with use of one 41239-06 7f td heparin coated catheter.It was reported that on 06/01 approximately ten minutes into the procedure" the balloon came off".It was also reported that " the patient did not have any side effects per the cardiologist".
 
Manufacturer Narrative
Device return: pending.Initial investigation: a review of the mfg.Lot build database for the reported lot # 31-114-y1 (mfg.Date 08/2013) shows 151 units were mfg.Tested inspected and released.There were no exception documents generated during the mfg.Lot build.
 
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Brand Name
TD TORQUE LINE CATHETER
Type of Device
TD TORQUE LINE CATHETER
Manufacturer (Section D)
ICU MEDICAL, INC.
salt lake city UT 84123
Manufacturer Contact
terry scesny
4455 atherton dr.
salt lake city, UT 84123
8012641400
MDR Report Key4203903
MDR Text Key16183393
Report Number2025816-2014-00090
Device Sequence Number1
Product Code DYG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 07/11/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number41239-06
Device Catalogue Number41239-06
Device Lot Number31-114-Y1
Other Device ID NumberPR# 25982
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date06/01/2014
Event Location Hospital
Date Manufacturer Received06/13/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/01/2013
Is the Device Single Use? Yes
Type of Device Usage Reuse
Patient Sequence Number1
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