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

Model Number N/A

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Cramp(s) /Muscle Spasm(s) (4521)

Event Date 08/31/2020

Event Type  malfunction  

Manufacturer Narrative

Expiration date - unknown due to unknown product code and lot number. Udi: unknown due to unknown product code and lot number. Implanted date: device was not implanted. Explanted date: device was not explanted. Device manufacturer date - unknown due to unknown product code and lot number. Pma/510(k): unknown due to unknown product code and lot number. 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. The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.

Event Description

The user facility reported progreat coaxial. Device malfunction, despite careful advancement of the guidewire, it caused spasm at the radial artery. Additional information was received on 22sept2020. There was only one device used, and caused spasms. The procedure being performed was a uterine fibroid embolization. The procedure was completed through radial access. There was no blood loss. There was no medical intervention required. It should have been the wire in the slender sheath kit, it was stated that it felt too stiff. Additional information was received 24sep2020. The progreat coaxial was not the device that malfunctioned, it should have been the wire in the slender sheath kit. The doctor stated that it felt too stiff which caused spasm in the radial artery. Per the doctor, it was not the progreat that was the issue. He had issues with the nitinol wire that was in the slender kit. He said it felt more stiff than normal and he had to switch to a nitrix wire. There was some spasm; however, nothing that needed the case to get cancelled. The case was performed successfully, and no other issues had happened.

Event Description

Additional information was received on (b)(6) 2020. There was no patient injury, medical/surgical intervention required. The patient's condition was stable, resolved. The procedure outcome was successful. The glidesheath slender device was used for a radial access uterine fibroid embolization procedure. According to the attending physician, despite careful advancement of the guidewire, it caused spasm at the radial artery. Angiography demonstrated normal-appearing artery anatomy; no variant anatomy noted. Radial artery vessel size was reported as 2. 6mm.

Manufacturer Narrative

This report is being submitted as follow up no. 1 to provide additional information in sections a1, a4 and b5, to update sections d1, d4, g4 and h4, and to provide the completed investigation results. The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted. A review of the device history record of the product code/lot# combination was conducted with no findings. The complaint cannot be confirmed since the sample was not returned for evaluation. Based on the information given, the exact root cause of the event cannot be determined since it is unclear if the device failed to meet any specifications and the relationship of the device to the alleged minor spasm cannot be confirmed. There is no indication that any manufacturing, design or quality system issues may have led to this event. Currently, no action is recommended since this risk evaluation is within the predetermined limits in the 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: 10618768
• Report Number: 1118880-2020-00257
• Device Sequence Number: 1
• Product Code: DYB
• 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
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 50-1050
• Device Lot Number: YC12
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Age: 48 YR
• Patient Weight: 127