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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CREGANNA MEDICAL GORE TIPS SET; INTRODUCER, CATHETER
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CREGANNA MEDICAL GORE TIPS SET; INTRODUCER, CATHETER Back to Search Results
Model Number TSET1016
Medical Device Problem Codes Break (1069); Crack (1135)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/21/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported the physician selected a gore tips set for a femoral vein recanalization procedure.It was further reported that the sheath broke in half.They were able to retrieve all but a small piece of the sheath which remains in the patient.
 
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Brand Name
GORE TIPS SET
Common Device Name
INTRODUCER, CATHETER
Manufacturer (Section D)
CREGANNA MEDICAL
parkmore west
galway H91 V N2T
EI  H91 VN2T
MDR Report Key12240813
Report Number2017233-2021-02197
Device Sequence Number1494121
Product Code DYB
UDI-Device Identifier25391526210028
UDI-Public25391526210028
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K152913
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Importer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date06/23/2023
Device Model NumberTSET1016
Device Catalogue NumberTSET1016
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2021
Distributor Facility Aware Date04/22/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date07/28/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age35 YR
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