MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION R2P DESTINATION SLENDER GUIDING SHEATH; INTRODUCER, CATHETER

Model Number N/A

Device Problem Difficult to Remove (1528)

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

Event Date 08/02/2021

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was 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.A review of the device history record of the product code/lot# combination was conducted with no findings.

Event Description

The user facility reported the involved r2p destination sl sheath device was used in a left r2p procedure.Metacross r2p 4mmx60 became stuck within sheath upon removal.The balloon was advanced back into the artery and removal was attempted for a second time unsuccessfully.The system was then pulled back into the radial artery.The sheath was separated proximally.The physician cut the proximal sheath and hub off balloon and pulled the sheath off balloon and wire, he then to expose the rx port of balloon and wire was replaced with.018-inch wire through rx port of balloon.The balloon was then removed, and a new short radial sheath was inserted.The r2p procedure was successful.The patient condition was stable.Additional information was received on 04august2021: the tortuosity was not visible.The vascular surgeon chose the radial approach.Upon removal of the sheath and prior to removing the lodged balloon, they were able to maintain wire access through the rapid exchange port of the metacross by placing an.018 wire and removed the remainder of the balloon / sheath and exchange for a 6fr slender.They then used a.018 6x40 crosstella r2p at the target lesion.This balloon popped upon attempted removal through the glidesheath and was successfully retrieved.There was no patient injury.The final run was taken, and procedure was deemed successful.A tr band was applied, and representation remained on hand until band was removed.There was no complications or patient injury noted.Follow up conversation with the physician 1 day post op determined patient was discharged without any issue.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date in section d9 and update section h3.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.

Manufacturer Narrative

This report is being submitted as follow up no.2 to update section h3, and to provide the completed investigation results.One r2p destination slender was returned product evaluation.The returned sample included the sheath.A metacross balloon was observed to be stuck in the sheath.The sheath was subjected to visual analysis.The sheath was separated into 4 pieces.The first piece was 2.9cm from the hub.The coiling still connected both pieces.The second piece was measured to be 30.5cm in length.The 3rd breakage was found to be 77.0cm in length.The 4th piece was 99.2cm.The balloon was cut at 31.4cm from the tip.The sheath showed signs of accordioning, stretching, compression and flattening along its length.The complaint can be confirmed for mechanical separation.The exact root cause cannot be determined.It is likely that pulling forces during withdrawal of the sheath in the presence of resistance likely caused the breakage.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: R2P DESTINATION SLENDER GUIDING SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 12374160
• MDR Text Key: 268495962
• Report Number: 1118880-2021-00191
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00389701011547
• UDI-Public: 00389701011547
• Combination Product (y/n): N
• PMA/PMN Number: K193125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C12W
• Device Lot Number: XP18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Date Manufacturer Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GWA, .018 INCH WIRE