MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION GLIDESHEATH SLENDER; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier - va does not release patient info.Age & date of birth - va does not release patient info.Patient sex - va does not release patient info.Weight - va does not release patient info.Ethnicity - va does not release patient info.Race - va does not release patient info.Implanted date: device not implanted.Explanted date: device not explanted.The actual device was not returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record of the product code/lot# combination was conducted with no findings.
Event or Problem Description
The user facility reported that the doctor had a patient he was reviewing that had a radial to peripheral (r2p) procedure ten-day prior which had to have open surgery on.The doctor stated that the patient had to have their hand opened and black pieces of the access wire that had sheared off were removed.The patient condition was stable.Additional information was received on 06 oct 2022: there was minimal blood loss.The procedure was successful in removing the black pieces.A 60-1050 wire was used with a 80-1050 needle.They did not use the a-kit wire with the sheath designed for the a-kit.The needle sheered off the wire into the hand.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.1 to provide a correction to section d4 as the catalog number was inadvertently reported as 30-1050 when the correct product code should have been 60-1050 and to proved the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The complaint cannot be confirmed since the device was not available for evaluation.The exact root cause cannot be determined.The likely root cause is using a plastic guidewire with a metallic needle.The device history record (dhr) could not be reviewed since the lot number was not available.There is no indication that any manufacturing issues may have led to this event.Currently no action is recommended since this risk evaluation is within the predetermined limits in the failure mode & effects analysis (fmea).

• Brand Name: GLIDESHEATH SLENDER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer Contact: gina digioia ; 950 elkton blvd.; elkton, MD 21921 ; 6402040886
• MDR Report Key: 15569138
• Report Number: 1118880-2022-00075
• Device Sequence Number: 5593249
• Product Code: DYB
• UDI-Device Identifier: 00389701011219
• UDI-Public: 00389701011219
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K152713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2024
• Device Model Number: N/A
• Device Catalogue Number: 60-1050
• Device Lot Number: 0000176640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 10/10/2022
• Supplement Report FDA Received Date: 10/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown