MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC SPIN ACCESS CATHETER 90 DEGREES

Model Number INS-5910

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2022

Event Type  Injury  

Event Description

Doctor has a spin access catheter 90 degree handle break off while attempting to turn the catheter.There was a delay in procedure for 30 minutes.The procedure was aborted.

Manufacturer Narrative

This report is being supplemented to provide information that was inadvertently not provided in the initial medwatch report, to correct information provided in the initial report, and to provide the results of the investigation of the event.Correction to b1, b2, and h1: this event is considered to be an adverse event/serious injury due to the 30 minute procedure delay and procedure being discontinued after the patient was under anesthesia.G3 of the initial medwatch report was blank.The date received by manufacturer was 10-mar-2022.A full investigation could not be completed due to the device not being returned for evaluation, as it was discarded by the facility.The investigation found that the drawing for the device does not provide specifications for handle attachment.There are no specific inspection requirements for the handle.A root cause of the reported event could not be determined.Veran will continue to monitor field performance for this device.This supplemental report is being submitted as a corrective action following a retrospective review of complaints in response to an observation from an external inspection.

• Brand Name: SPIN ACCESS CATHETER 90 DEGREES
• Type of Device: CATHETER
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC; 1938 innerbelt business center; saint louis MO 63114
• Manufacturer (Section G): VERAN MEDICAL TECHNOLOGIES, INC; 1938 innerbelt business center; saint louis MO 63114
• Manufacturer Contact: jennifer andre ; 1938 innerbelt business center; saint louis, MO 63114 ; 3146598500
• MDR Report Key: 13725570
• MDR Text Key: 289767412
• Report Number: 3007222345-2022-00009
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 00815686021276
• UDI-Public: 00815686021276
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2023
• Device Model Number: INS-5910
• Device Catalogue Number: INS-5910
• Device Lot Number: 85028200116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2020
• 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): Other