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

Model Number	N/A
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.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.A review of the device history record of the product code/lot# combination was conducted with no findings.
Event or Problem Description
The user facility reported that the r2p guiding sheath was broken.The r2p destination sl guiding sheath was inserted into the artery after being assembled with the dilator.As the lesion was at the bifurcation of the common iliac artery as well, the physician thought that marking right under the ostial was necessary using ivus.The physician therefore attempted to replace the guiding sheath with another guiding sheath of a different size (120 cm).When the tip of the guiding sheath was withdrawn to the subclavian region, the guiding sheath encountered high resistance and it was difficult to be pulled out furthermore.This seemed to have occurred due to a spasm.After a vasodilator was administered and a certain period of time had passed, the pitch of the coil at the tip of the guiding sheath was found to have separated and seemed to have stretched.After a while, the guiding sheath was slowly withdrawn and successfully removed from the patient.A glidesheath slender was inserted to replace the guiding sheath with a slenguide guiding catheter (120 cm).The procedure was successfully completed.There was no patient injury, medical/surgical intervention required.There was no health damage to the patient.The blood loss was reported to be unknown.There were no other devices or equipment used with the reported product.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information to section b5, update section h3, and to provide the completed investigation results.H6: investigation findings- 114 is based upon the evaluation of user facility information; 213 is based upon testing of the returned sample.H6: investigation conclusion- 4310 is based upon evaluation of the user facility information; 67 is based upon testing of the returned sample.One 149 cm 6fr r2p destination sheath, valve assembly, and dilator were received for product evaluation.The sheath was returned with all components fully assembled.The sheath was subjected to visual inspection and no damage was noted on the device.The tip was viewed under microscope and no damage was noted.The coiling style at the distal end of the sheath is a conforming state.The length of the sheath measured to be 148.6 cm which is within specifications.The complaint cannot be confirmed for sheath mechanical damage.Per the complaint description, the customer experienced resistance during withdrawal of the sheath likely due to spasm in the patient's vasculature however, this event did not cause any sheath mechanical damage.The device returned for evaluation did not have any damage at the sheath tip and it was not elongated either.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).
Event or Problem Description
Additional information was received on 07june2021: the event that occurred was confirmed for the pitch of the coil at the tip of the guiding sheath was found to have stretched.Tucking was performed after the coiling process therefore the end part of the coil was tucked beneath to prevent unravelling.There was also gaps present between the coils.

• Brand Name: R2P DESTINATION SLENDER GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 11737078
• Report Number: 1118880-2021-00086
• Device Sequence Number: 11720605
• Product Code: DYB
• UDI-Device Identifier: 00389701011561
• UDI-Public: 00389701011561
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C15W
• Device Lot Number: YC11A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VASODILATOR; VASODILATOR
• Outcome Attributed to Adverse Event: Required Intervention