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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC SAFESEPT TRANSSEPTAL GUIDEWIRE; TROCAR
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PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC SAFESEPT TRANSSEPTAL GUIDEWIRE; TROCAR Back to Search Results
Model Number SS-135
Device Problem Entrapment of Device (1212)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/07/2021
Event Type  malfunction  
Event Description
Wire weld point is about 2cm from the wire tip and is catching on the septum/heart tissue when passing through.This has gotten worse over time.Two failures were saved, and both are available to return to the manufacturer.Product had patient contact but no patient harm.Manufacturer response for safesept wire 135cm, (brand not provided) (per site reporter).The product returned for evaluation.
 
Event Description
Wire weld point is about 2cm from the wire tip and is catching on the septum/heart tissue when passing through.This has gotten worse over time.Two failures were saved, and both are available to return to the manufacturer.Product had patient contact but no patient harm.Manufacturer response for safesept wire 135cm, (brand not provided) (per site reporter) the product returned for evaluation.
 
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Brand Name
SAFESEPT TRANSSEPTAL GUIDEWIRE
Type of Device
TROCAR
Manufacturer (Section D)
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC
3816 desoto blvd
palm harbor FL 34683
MDR Report Key11912632
MDR Text Key253557109
Report Number11912632
Device Sequence Number1
Product Code DRC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 05/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSS-135
Device Catalogue NumberSS-135
Device Lot Number000850
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/20/2021
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/21/2021
Event Location Hospital
Date Report to Manufacturer06/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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