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

Model Number	N/A
Medical Device Problem Codes	Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	03/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.A review of the device history record of the product code and lot number combination was conducted with no findings.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 they has a (st elevation myocardial infarction) stemi percutaneous coronary intervention (pci) case with access via the right radial with a 6fr x 10cm glidesheath slender.Treat culprit lesion in right coronary artery (rca).They attempted to engage left coronary artery (lca) to image and treat, if necessary.However, anatomy was challenging and could not engage.They prepped a destination slender and advanced over guidewire, it advanced smoothly until tip of sheath reached shoulder region.It could not be advanced further or withdrawn.After a while they gained femoral access in attempt to get sheath unstuck the user facility reported the involved r2p treatment, a 0.035-inch guidewire was pre-inserted into the dilator of the guiding sheath and the dilator was inserted into the artery to be mated with the catheter for retrieval.The guiding sheath was attempted to be retrieved; however, resistance was felt.The guiding sheath was withdrawn slowly, not at once but several times, but resistance became higher.When the guiding sheath was checked, it was found to be stretched; the tip of the catheter was located above the elbow and the tip of the dilator was located around the forearm.The guiding sheath was again attempted withdrawn, but it could not be removed due to spasm.Vasolan (vasodilator) was administrated and waited for thirty (30) minutes for the spasm to release, but the resistance remained the same.The guiding sheath was straight and attempted to be withdrawn it slowly, the guiding sheath became gradually withdrawn and was eventually removed from the patient.The procedure was successfully completed.No health damage for the patient.The estimated blood loss was less than 250cc's.The event occurred intra-operative.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 update section h3, and to provide the completed investigation results.One r2p sheath and dilator were returned to for assessment.The sample was subject to visual analysis.The dilator is not fully inserted into the sheath.The dilator cannot be removed from the sheath.The hub is screwed on tightly.The hub is compressed.The sheath tip is deformed.The sheath was measured and found to be 141.5cm in length.There are stretched regions 32.2-32.4cm and 109.8-112.4cm from the sheath hub.The complaint can be confirmed for stretching of the sheath during withdrawal.The exact root cause cannot be determined.The likely root cause is the sheath stretched due to increased resistance from a spasm, leading to difficulties during withdraw.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.Currently no action is recommended since this risk evaluation is within the predetermined limits in the design failure mode and effects analysis (dfmea).

• 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: 16841280
• Report Number: 1118880-2023-00063
• Device Sequence Number: 6889120
• Product Code: DYB
• UDI-Device Identifier: 00389701011547
• UDI-Public: 00389701011547
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2023

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: 07/01/2024
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C12W
• Device Lot Number: 0000146585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 04/29/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 36 KG