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

Model Number	N/A
Medical Device Problem Codes	Material Separation (1562); Stretched (1601)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	04/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that a destination slender and a 4fr catheter were used radial to record the patient's pressure.The procedure started with a 6 fr terumo short sheath, then a 0.035" wire was used to exchange a destination device.The destination device was advanced without much resistance, however; when the end got to the subclavian, the patient had pain.The device was not advanced into the ascending aorta due to the patient's pain.The sheath was left to monitor pressures and was flushed continuously.Secondary access was achieved through the femoral artery with the destination device involved and used with a 4 fr catheter to measure pressures in the heart.When complete, a 0.035" wire was attempted to be put through the destination slender, it was noticed on fluoroscopy that the sheath looked stretched/broken.The dilator was attempted to be put back in, but it would not go.Another catheter was tried, but it would not go.When the sheath was pulled back, the patient had pain when the tip was between the shoulder and elbow.There seemed to be a spasm, but the patient couldn't be put under further sedation due to a risky body mass index (bmi) (50).The sheath broke at the junction of the skin, and it was confirmed under fluoroscopy that there was approximately 35 centimeters of the device still in the patient's arm.Parts of the sheath looked ok, other parts looked stretched.The patient went to the operating room (or) and the surgeon was able to easily remove the remainder of the sheath.The patient seemed to be well, but that night the patient experienced pain in the arm.A scan was done, and it appeared that a piece of the tip may still be in the artery.At that time, it didn't appear to be a complete occlusion.Prior to surgery, the sheath was in place in the arm/subclavian for 1 hour and 30 minutes.Additional information was received on 08 apr 2022: the patient was in stable condition.The patient continued to have good pulses.Additional information was received on 12 apr 2022: the doctor confirmed that the sheath fragment was removed surgically, and a radial spasm took place after introducing the catheter.
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has been returned for evaluation.One r2p was returned to terumo medical corporation for product evaluation.The returned sample included the sheath and sample packaging.The length of the returned sheath was 56.8 centimeters.The tip portion of the sheath was not returned.There were pinches on the sheath located at 9.0cm to 10.4 centimeters, 18.6 centimeters to 19.4 centimeters, 22.6 centimeters to 23.8 centimeters, 39.2 centimeters to 40.0 centimeters, and 42.0 centimeters to 42.7 centimeters from the sheath hub.The sheath was stretched from 29.8 centimeters to 34.3 centimeters and 49.1 centimeters to 56.8 centimeters from the sheath hub.The sheath was compressed 48.1 centimeters to 49.1 centimeters.The sheath was flattened from 52.6 centimeters to 56.8 centimeters.The coil was loose on the last 0.5 centimeters of the sheath shaft.The pebax was observed to be missing from that portion of the sheath.The swage band was intact.A piece of polytetrafluoroethylene (ptfe) tubing was returned.The tubing was measured to be approximately 6.5 centimeters and torn down the middle.A coil approximately 11 centimeters long was also returned.The complaint can be confirmed for mechanical separation.The exact root cause cannot be determined.The likely root cause is pulling the sheath after the vessel spasm occurred.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.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
• 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: 14279662
• Report Number: 1118880-2022-00026
• Device Sequence Number: 17692182
• Product Code: DYB
• UDI-Device Identifier: 00389701012360
• UDI-Public: 00389701012360
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K193125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/03/2022

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: 05/01/2023
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C75W
• Device Lot Number: 0000008033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2020
• 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: 0.035" GUIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 132 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White