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

Model Number TSET1016

Device Problems Break (1069); Crack (1135)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/21/2021

Event Type  Injury  

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 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
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): CREGANNA MEDICAL; parkmore west; galway H91 V N2T; EI H91 VN2T
• Manufacturer (Section G): CREGANNA MEDICAL; parkmore west; galway H91 V N2T; EI H91 VN2T
• Manufacturer Contact: marci stewart ; 1505 n. fourth street; flagstaff 86004 ; 9285263030
• MDR Report Key: 11864012
• MDR Text Key: 252139132
• Report Number: 2017233-2021-02022
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 25391526210028
• UDI-Public: 25391526210028
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152913
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2023
• Device Model Number: TSET1016
• Device Catalogue Number: TSET1016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR