MAUDE Adverse Event Report: CREGANNA MEDICAL GORE TIPS SET; INTRODUCER, CATHETER

Model Number	TSET1016
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Due to system errors, this importer report from (b)(4) is being sent as a manufacturing report.Please note the pertinent information below.Manufacturer information: (b)(4).Mfr report #: 3004193842-2021-00001 (sent 06-may-2021).Importer information: (b)(4).Date user facility or importer became aware of event: (b)(6) 2021.Date report sent to manufacturer: 22-apr-2021.
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.

• 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 Key: 11864012
• Report Number: 2017233-2021-02022
• Device Sequence Number: 922520
• Product Code: DYB
• UDI-Device Identifier: 25391526210028
• UDI-Public: 25391526210028
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K152913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2021

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 Date: 06/23/2023
• Device Model Number: TSET1016
• Device Catalogue Number: TSET1016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR