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

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: cath lab manager.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.
Event or Problem Description
The user facility reported that the involved destination device was used for an intervention for an ostial right coronary artery (rca).The doctor gain radial access through the left radial artery and placed a 75 cm r2p destination.Upon completion of the intervention, the physician attempted to remove the sheath but was stuck.He then gave versed, waited some time before attempting to remove the sheath, then decided to take the patient to the or for surgical removal.The event occurred intra-operative.There is not a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.Additional information was received on 01 mar 2024: the device began to have issues during removal.The device had to be surgically removed.The device fell apart during the removal process.The patient received versed.The patient had areas of plaque.They were having a percutaneous coronary intervention (pci) of the proximal rca.The patient experienced loss of radial artery.The patient is stable and has likely been discharged home.There were normal items, guide catheter, wire, and balloon/stents used with the r2p destination.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to correct section d9 and to provide the completed investigation results.One r2p sheath was sent to for evaluation.The sample was subject to visual analysis.A portion of the sheath was returned.The sheath fragment is 18.2cm in length.The sheath tip is deformed.The distal end is stretched and uncoiling.The complaint can be confirmed by a sheath separation.The exact root cause cannot be determined.The chief medical officer and npd quality engineer were notified about this complaint and determined with the limited information provided, the cause of the sheath separation is unknown.It is possible the areas of plaque increased resistance during withdraw and led to the sheath separation.The r2p ifu (instructions for use), was reviewed and it states: "caution: while inserting or withdrawing, if resistance is met, do not advance or withdraw the sheath until the cause of resistance has been determined." review of device history record (dhr) showed there were no issues noted during manufacture of the product that could have contributed to this complaint condition.Action item was initiated for the occurrence breach in the r2p hazard based risk table.

• Brand Name: R2P¿ DESTINATION SLENDER¿ GUIDING SHEATH
• Common Device Name: 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: gina digioia ; 950 elkton blvd; elkton, MD 21921 ; 6402040886
• MDR Report Key: 19008983
• Report Number: 1118880-2024-00038
• Device Sequence Number: 8445847
• Product Code: DYB
• UDI-Device Identifier: 00389701012360
• UDI-Public: 00389701012360
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2024

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: 04/01/2026
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C75W
• Device Lot Number: 0000430017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 03/30/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER, WIRE, & BALLOON/STENTS
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female