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

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 07/28/2021

Event Type  malfunction  

Manufacturer Narrative

Pt info: unk.Implanted date: device not implanted.Explanted date: device not explanted.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.

Event Description

The user facility reported that the guidesheath slender wire would not feed through the needle easily.They ended up getting it to work but had issues.The patient was in stable condition.The procedure outcome was successful.The blood loss was less than 250cc's.There was no patient injury, medical/surgical intervention required.There were no other devices or equipment used with the reported product.Additional information was received on 30july2021: the procedure performed was a left heart catheterization.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date in section d9 and to update section h3.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.

Manufacturer Narrative

This report is being submitted as follow up no.2 to update section h3, and to provide the completed investigation results.One 6fr glidesheath slender was returned for product evaluation.The returned sample included the sample label, needle, and guidewire.The guidewire and needle were subjected to visual analysis.No signs of damage were observed on the guidewire.The proximal end on the needle was inspected and no blockage was observed.Functional testing was attempted to be performed.The guidewire was attempted to be inserted into the needle.Resistance was felt.Measurements were taken of the guidewire.The guidewire was found to be 0.019" (0.4826) which is within specification of =/< 0.54 mm.Measurement was attempted to be taken of the needle but there was resistance to inserting any size pin gauge which hinted at a blockage in the needle shaft.The stiff end of the guidewire was used to push the blockage out.The blockage was observed to be from dried blood-like substances.Functional testing was performed again after the blockage was removed and the needle went through the guidewire completely.The complaint cannot be confirmed for needle and guidewire mobility.The exact root cause of the failure cannot be determined.The dhr review determined that the device was in a conforming state when released from terumo control.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 and effects analysis (fmea).

• Brand Name: GLIDESHEATH SLENDER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 12349126
• MDR Text Key: 267517734
• Report Number: 1118880-2021-00190
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00389701012063
• UDI-Public: 00389701012063
• Combination Product (y/n): N
• PMA/PMN Number: K173831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2023
• Device Model Number: N/A
• Device Catalogue Number: 80-1060
• Device Lot Number: 0000043138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Date Manufacturer Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1