MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA R2P SLENGUIDE; CATHETER, PERCUTANEOUS

Catalog Number WG-S7ST1L23J

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 09/09/2021

Event Type  malfunction  

Manufacturer Narrative

Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.This reported event has been deemed not reportable based off the evaluation of the actual sample.A misago and a slenguide were returned for evaluation investigation of these actual samples were performed together as follows.Inspection of the actual samples: visual inspection of slenguide found a stretching of the shaft in the range of about 995 mm to 1210 mm from the distal end.Magnifying inspection of the slenguide found that the distal tip had been broken and partially missing.The inner diameter of the slenguide was measured on the area except for the stretched area and confirmed to meet the control standard.No dimensional anomaly was observed.Visual inspection of the misago found that the stent had dislodged while the deployment handle was locked.The distal section of the misago was inspected under a magnifier and electron microscope.Multiple scratches were observed over the entire circumference of the distal tip, and the distal edge of the sheath had been turned up slightly in the proximal direction.Based on the circumstances of the occurrence and the condition of the actual samples, it was assumed that the misago was caught in the stretching part of the slenguide, and then the operator pushed the misago further in with an intension to pass it through the slenguide.The outer diameters of the misago were measured at the intact sections of the distal tip and the sheath and confirmed to meet the control standard.An attempt to insert the misago into the slenguide showed that the misago was caught at approximately 1210 mm from the distal end of the slenguide.Simulation test: the following simulation test was conducted with factory retained slenguide and misago samples.A tensile load was applied to the slenguide causing a partial stretching of about 10 mm, and then the misago was inserted into the slenguide.As a result, the misago became caught in the stretched area of the slenguide.After the misago in that caught state was pushed further, it was pulled from the slenguide.As a result, the sheath retracted and the stent partially self-expanded.A review of the device history record and the shipping inspection records for the involved slenguide and the misago of the involved product code/lot# combination was conducted with no findings.Ifu states: repeat the pre-dilatation step if you feel any resistance (advancing the stent system by force can potentially damage the blood vessel and/or break or damage the stent system.).Do not deploy the stent until it is properly positioned.(if the stent is deployed in an incorrect position, it may not expand fully.) ensure that the stent is not positioned within the introducer sheath, guiding sheath, or guiding catheter.(deploying the stent within the introducer sheath, guiding sheath, or guiding catheter may deform the stent or damage the delivery catheter.) avoid deploying the stent in positions that could hamper access to major vessel branches.(this could compromise future diagnostic or therapeutic procedures.) the stent should not come into contact with non-nitinol stents.(contact between stents made from two different materials can result in potential corrosion of the stents.) based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that the lumen of the slenguide narrowed due to stretching of its shaft, and the misago became caught in it during insertion.As the misago in that caught state was pushed further, the sheath retracted, and the stent expanded inside the slenguide.As the misago was removed from the slenguide while the stent was in the expanded state, the stent became caught in the narrow part such as the stretching area or in a y-connector.When the stent was withdrawn from the slenguide, the deployment handle had not been rotated yet.The tip of the slenguide was found to be damaged and partially missing, but since it was not pointed out in the complaint, it was considered that there was no causal relationship with this case.The exact cause of the reported event cannot be definitively determined based on the available information.This report is for the slenguide device reported, for the reported misago device, please see mdr 9681834-2021-00169.(b)(4).

Event Description

The user facility reported that the r2p slenguide was used during the procedure.In a radial approach, the slenguide was inserted into a 6/7f glidesheath, a balloon was used for pre-dilatation, and then a stent was inserted in the slenguide.The stent met resistance when passing the proximal part of the slenguide.The stent was removed and the slenguide was removed also.The slenguide had been elongated entirely.135cm misago was inserted from femoral, and stenting was done.The patient was not harmed.The procedure outcome was not reported.

• Brand Name: R2P SLENGUIDE
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: mary o'neill ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 12604555
• MDR Text Key: 279588740
• Report Number: 9681834-2021-00174
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: WG-S7ST1L23J
• Device Lot Number: 210319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2020
• 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