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

Model Number N/A

Device Problems Break (1069); Unraveled Material (1664)

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

Event Date 06/06/2022

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter occupation: nurse manager.The actual device has 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 destination slender's exterior coil unraveled upon removal from the artery.The patient was not harmed, and it did not affect the outcome of the case.Additional information was received on 08 jun 2022: the procedure was a peripheral fixing left iliac.The physician was able to pass the destination slender from the right radial to the left iliac and was able to treat with crosstella balloons.When the doctor repositioned the destination, slender there were severe spasms and this was when the destination broke.The break was outside of the patient.A balloon was still advancing through the destination slender which was and used as a dilator to remove the rest of the destination slender along with the balloon and leaving the wire down the iliac.Once removed another destination slender was placed down to finish treating the iliac.The rest of the case was successful and had a good outcome to fixing the iliac.The patient was stable, and doing well.There was no blood loss.

Manufacturer Narrative

This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.One r2p destination slender was returned for product evaluation.The returned sample included the sheath.The sample was decontaminated per terumo procedures and policies.The sample was subjected to visual analysis.A balloon was inserted through the sheath hub.The swage band was found to be in the sheath hub.The r2p sheath was in two pieces.The first piece was 18.8cm long.The coil at the breakage point on the first piece unraveled at 18.1cm and extended to 19.7cm from the sheath hub.The second piece was 105.2cm.The balloon shaft had extended 71cm from the sheath tip.There were signs of kinking, compression, pinching and other forms of deformation on sheath shaft.The complaint can be confirmed for mechanical separation.The exact root cause cannot be determined.The likely root cause is continued withdrawal of the sheath prior to alleviating the spasm.Review of the device history record (dhr) showed there were no issues noted during manufacture of the product that could have contributed to this complaint condition.This complaint was added to the scope of a non-conformance (nc) for risk level increase.

• Brand Name: R2P¿ DESTINATION SLENDER¿ GUIDING SHEATH
• Type of Device: 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: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 14799712
• MDR Text Key: 302611918
• Report Number: 1118880-2022-00050
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00389701011547
• UDI-Public: 00389701011547
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2024
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C12W
• Device Lot Number: 0000089822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2022
• Initial Date Manufacturer Received: 06/06/2022
• Initial Date FDA Received: 06/24/2022
• Supplement Dates Manufacturer Received: 07/27/2022
• Supplement Dates FDA Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• 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
• Treatment: CROSSTELLA BALLOON.