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 Code	Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	04/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: inventory specialist.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 or Problem Description
The user facility reported that the r2p sheath was placed in the anterior tibial artery.Upon removal of the sheath there was a slight resistance, which may have been a spasm.The sheath continued to be removed gently despite the resistance.Once the sheath exited the body there was noticeable elongation of the sheath, and upon examination the hospital staff noticed the sheath stretched and had begun to separate, and then they pulled it apart resulting in a full separation of the sheath.The patient was in stable condition.The procedure outcome was successful.The patient was not injured during the event and medical or surgical intervention was not required to prevent injury.Additional information was received on 21 april 2022: the procedure performed was a lower extremity angiogram.The event occurred upon removal of the sheath, so the procedure was completed.The sheath was able to be fully removed because it stayed intact enough to remove.Though, when the procedure was completed and the device removed, the hospital staff examined the device and were able to pull in apart without much effort.The device separated on the back table after removal from the body.While removing the staff noticed the sheath had noticeable damage (described as sheath stretching and elongation), but it remained intact until it was out of the body.There was no blood loss.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.1 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.The sheath was completely separated.The first piece, where the sheath hub was located, was measured to be measured 12.3cm.And the second piece, where the sheath tip was located, was measured to be 64.6cm.There was slight elongation at near the breakage sites.There were no other signs of damage found on the first piece.The swage was band was found to be intact.There was a pinch on the second piece at 22.2cm to 23.5cm from the breakage point.A kink was located on second piece 44.9cm from the breakage point.The tip on the sheath was found to be deformed.The complaint can be confirmed for mechanical damage.The exact root cause cannot be determined.The likely root cause is a resistance or spasm restricted withdrawal of the sheath, and the force was still applied in the face of the resistance.Review of vice 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: 14398435
• Report Number: 1118880-2022-00036
• Device Sequence Number: 5563923
• Product Code: DYB
• UDI-Device Identifier: 00389701012360
• UDI-Public: 00389701012360
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 05/13/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2023
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C75W
• Device Lot Number: 0000005686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2022
• 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: GLIDEWIRE ADVANTAGE; NAVICROSS, R2P METACROSS; R2P CROSTELLA, GLIDEWIRE ADVANTAGE TRACK 018
• Patient Sex: Unknown