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

Model Number	GS-R6ST1C10W
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted d6b: explanted date: device was not explanted the actual device is not available for return.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 destination slender sheath unraveled in the radial artery due to spasm.Patient had to go for surgery and the device was removed during surgery.The procedure being performed was a superior mesenteric artery (sma) stenting.The patient was fine pre procedure, alert and awake.The estimated blood loss was less than 250cc.Additional information was received on 25sept2024: resistance was encountered upon removal due to spasm.We inflated blood pressure (bp) cuff higher up the arm, gave more nitro, patient was sedate as we had anesthesiologist for the case.The patient was stable.After cut-down and retrieving the sheath they gained access higher in the brachial and the superior mesenteric artery (sma) stenting was completed.The patient was a skinny older lady.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted, however, the account provided a photo of the r2p device, and the sheath was uncoiling near the sheath tip.The complaint can be confirmed for a sheath breakage based on the photo provided by the account.Without a sample, the exact root cause cannot be determined.The likely root cause is the patient spasm was not fully alleviated before attempted removal of the sheath.The spasm likely prevented the sheath from withdrawing due to increased resistance and led to the sheath breakage.The r2p ifu 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 the manufacture of the product that could have contributed to this complaint condition.Currently, no action is recommended since the risk evaluation is within the predetermined limits in the hazard based risk table (hbrt).
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.One tr band, inflator and packaging were returned for assessment.The sample was subject to visual analysis.No damage or deformities were noted on the band or inflator.There is 4.5ml of air left in the band.The sample was subject to leak testing.Approximately 18ml of air was injected into the band and submerged in a water bath for 30 seconds.Air bubbles were observed from the check valve.The sample failed leak testing.The check valve was deconstructed to check for damage or foreign matter.Upon deconstruction, a piece of foreign matter was found.The complaint can be confirmed for air leakage issues.The cause is foreign matter in the check valve.The operations quality engineer was notified about this issue and a non-conformance (nc) was initiated.The nc will contain root cause analysis and corrective actions.Review of dhr showed there were no issues noted during the manufacture of the product that could have contributed to this complaint condition.Currently, no action is recommended since the risk evaluation is within the predetermined limits in the hazard based risk table (hbrt).

• 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: stephanie handy ; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 20516008
• Report Number: 1118880-2024-00154
• Device Sequence Number: 15593317
• Product Code: DYB
• UDI-Device Identifier: 00389701012353
• UDI-Public: (01)00389701012353(17)261101(10)0000602773
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/23/2024

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 Model Number: GS-R6ST1C10W
• Device Catalogue Number: GS-R6ST1C10W
• Device Lot Number: 0000602773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 10/31/2024; 12/17/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 11/27/2024; 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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: .035" GLIDEWIRE.; 75CM SHEATH.; DESTINATION SLENDER GWA 0.035.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female