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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	04/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the involved guidesheath slender device sheath broke off in the patient.Part of the sheath was left between the shoulder and the wrist.The sheath went in easy, but patient was a little spasmatic and a smoker.The doctor referred to the vessel as approximately 3mm but very calcified.A viper wire was in at the time of extraction.The patient was given additional drugs before pulling.200 nitro and 100 fentanyl.The doctor put in a couple sutures that stopped the bleeding and the patient was transferred to another hospital for vascular care/vascular surgeon.Patient was doing fine.Estimated blood loss was less than 250cc's.The patient was in stable and good condition.The procedure outcome was a success.Additional information was received on 26 april 2022: it was confirmed that the dilator was in the sheath when they went to withdrawal.All of the sheath was successfully removed by the vascular surgeon.Terumo medical received a user facility medwatch report # (b)(4) on 29 april 2022.The event description states: an elderly patient underwent peripheral vascular angiography for claudication, abnormal non-invasive studies, foot wound and peripheral arterial disease (pad).During the procedure, while the provider was slowly removing the sheath, patient sustained a severe spasm in the left radial artery despite intra- arterial nitroglycerin and anesthesia.The sheath fractured leaving a portion of the sheath from patient's left wrist to left shoulder in the vessel.Hemostasis was achieved with suture to radial artery proximal to the insertion site of the sheath.Patient was emergently transferred to another hospital for vascular surgery.Patient underwent left radial artery exploration, removal of the retained sheath and repair of the left radial artery.Patient tolerated procedure well and was discharged in stable condition the following day.Retained piece of sheath was successfully removed by vascular surgeon at another hospital during emergent procedure.Peripheral vascular angiography with possible intervention.Preexisting characteristics that may have contributed to the event are hypertension, smoking, and diabetes.The patient was hospitalized and required intervention to prevent permanent impairment/damage (devices).The original intended procedure was peripheral vascular angiography with possible intervention.Additional information was received on 29 april 2022: the procedure was an abdominal aortography, selective left leg angiography, csi atherectomy and balloon angioplasty to left superficial femoral artery (sfa).Indication, lifestyle limiting claudication, abnormal non-invasive studies, left foot wound and peripheral artery disease.The method: informed consent was obtained.The patient was placed in supine position.The left wrist was prepped and draped in sterile fashion.Subcutaneous lidocaine was administered.Under ultrasound guidance, the left radial artery was evaluated and measured 3 mm and was cannulated and a 5-french sheath was placed using seldinger technique.A 4 french pigtail catheter was advanced to the distal aorta and aortography was performed with iliac runoff.The catheter was then exchanged over a wire and a long multipurpose catheter was advanced into the left common femoral artery over a wire and the wire removed selective left leg angiography performed.Following this the wire was reinserted and the multipurpose and 5 french sheaths were exchanged for a 6 french 149 cm interventional sheath.Following further angiography and percutaneous intervention the dilator was reinserted over a wire and the sheath was slowly pulled back.Unfortunately, a severe spasm was present in patients left radial artery despite intra-arterial nitroglycerin and anesthesia.The sheath fractured leaving a portion of the sheath from her left wrist to her left shoulder in the vessel.Despite hemostasis with a radial band and blood pressure cuff to remain quite a bit of bleeding still therefore a 0-silk suture was utilized to ligate the radial artery proximal to the insertion site of the sheath.The blood pressure cuff was removed, and a radial hemostasis band applied for additional hemostasis at the sheath insertion site.This proved to be successful in achieving hemostasis thankfully.Ems was summoned and the doctor with vascular surgery at the hospital was called and agreed to take the patient urgently for evaluation due to the retained sheath.Patient was hemodynamically stable despite this.Under ultrasound visualization, her left ulnar artery was visible and pulsatile.The anticoagulation was heparin 8000u.Findings: the abdominal aorta was normal caliber with no focal aneurysm or stenosis.There does not appear to be high-grade stenosis in patient's right common or external iliac artery.The left common and external iliac artery appeared to be free of obstructive disease.Selective left leg angiography revealed a normal appearing common femoral and profunda femoris artery with a diffusely diseased left sfa with 100% occlusion in the mid to distal portion.Collateralization is present.The popliteal artery is patent and there is multivessel runoff to the foot.Intervention: after crossing through the high-grade occluded left mid to distal sfa, intraluminal position confirmed by angiography.The vessel was pretreated with a 4 mm balloon with low-pressure inflations to exchange the wire with the viper catheter.Following wire exchange and placement of a viper wire, a 1.5 solid csi device was used for serial atherectomy passes performed at low, medium, and high speeds.Following this multiple balloon inflations performed throughout the lesion with 4- and 5-mm balloons.An excellent angiographic result was obtained.Conclusion - successful csi atherectomy and balloon angioplasty to left sfa.Patient will be transferred to the hospital for urgent vascular surgery, evaluation of left radial sheath fracture.Complications documented before study signed intra-procedure other vascular complications requiring treatment.List of medications given on (b)(6) 2022: 7:00:00: midazolam iv (versed) 5 mg/5ml injection: 1mg given route: intravenous.7:00:00: verapamil (lsoptin), 5 mg, nitroglycerin 200 mcg, heparin (porcine) 5,000 units: given.Route: intra-arterial.7:12:12: fentanyl (sublimaze) injection: 50 mog given route: intravenous.7:26:32: heparin in ns (heparin in ns (table) 2000-0.9 unit/l-% infusion: 1,000 ml given route: intra-arterial sile: sterile table/field.7:31:00: arterial sheath 5 fr.Left radial assessment: act result 171 seconds act result info: normal range for act is.89- 69 seconds.7:31:16: sodium chloride 0.9 % 1,000 ml verapamil (lsoptin) 5 mg, nitroglycerin 5 mg: given.7:33:04: heparin (porcine) injection: 3,000 units given route: per sheath comment: verified by lt.7:34:46: nitroglycerin syringe: 200 mcg given route: per sheath.7:37:58: nitroglycerin syringe: 100 mcg given route: per sheath.8:00:25: fentanyl (sublimaze) injection: 100 mcg given route: intravenous.8:02:00: arterial sheath 5fr.Left radial removed: removal date & time: (b)(6) 2022 08:02 placement date & time: (b)(6) 2022 07:00 sheath size: 5 fr.Line orientation: left sheath insertion site: radial placed by: (b)(6).8:03:08: midazolam iv (versed) 5 mg/5ml injection: 2 mg given route: intravenous.Additional information was received on 02 may 2022: when the sheath was ready to be pulled additional versed, fentanyl and nitro were administered.
Additional Manufacturer Narrative
Patient identifier: requested, not provided.Ethnicity: requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.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.For this reason, investigation (b)(4) has been referenced.
Event or Problem Description
Additional information was received (b)(6) 2022: the patient was a female, and a smoker.The patient did fine with the surgery and visited for a follow up with minor soreness, otherwise she is doing fine.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.1 to provide additional information to section a3, b5, b6, to update section h3, and to provide the completed investigation results.One r2p was returned for product evaluation.The returned sample included the sheath, dilator, and packaging label.The sample was subjected to visual analysis.The swage band was found to be intact.16.6cm of the dilator shaft was measured to be sticking out from the sheath valve.The sheath shaft was found to be stretched from 30.0cm from the sheath hub to the end of the returned portion.The dilator tip was measured to located 136.5cm into the sheath shaft from the sheath hub.There were pinches in the sheath shaft from 148.6cm to 150.3cm, 164.0cm to 170.0cm and 182.0cm to 183.0cm from the sheath hub.The returned sheath length was measured to be 183.0cm.The sheath tip portion was not returned.There were kinks on the dilator shaft at 11.5cm and 12.3cm from the dilator hub.The complaint can be confirmed for mechanical separation.The exact root cause cannot be determined.The likely root cause is a spasm restricted movement of the sheath, and the sheath was pulled in the face of that resistance that led to the breakage.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 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: 14471932
• Report Number: 1118880-2022-00038
• Device Sequence Number: 4504814
• Product Code: DYB
• UDI-Device Identifier: 00389701011561
• UDI-Public: 00389701011561
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2022

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: 02/01/2024
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C15W
• Device Lot Number: 0000057103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• 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: 4 MM BALLOO, VIPER CATHETER & CSI DEVICE; 5-FRENCH SHEATH & 4 FRENCH PIGTAIL CATHETER; 6 FRENCH 149 CM INTERVENTIONAL SHEATH; ARTERIAL SHEATH 5 FR.; CROSTELLA AND MISAGO; FENTANYL (SUBLIMAZE) INJECTION - 50MG; HEPARIN (PORCINE) 5,000 UNITS; HEPARIN (PORCINE) INJECTION - 3,000 UNITS; HEPARIN IN NS TABLE 2000-0.9 UNIT - 1,000 ML; LONG MULTIPURPOSE CATHETER; MIDAZOLAM IV (VERSED) 5MG/5ML INJECTION; NITROGLYCERIN 5MG, NITROGLYCERIN SYRINGE - 200MCG; SODIUM CHLORIDE .9% 1,000ML VERAPAMIL LSOPTIN 5MG; VERAPAMIL (LSOPTIN), MG, NITROGLYCERIN 200MCG
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White