MAUDE Adverse Event Report: COOK INC MICROPUNCTURE TRANSITIONLESS ACCESS SET; DYB INTRODUCER, CATHETER

Model Number G43870

Device Problem Material Separation (1562)

Patient Problems Stroke/CVA (1770); Intracranial Hemorrhage (1891); Foreign Body In Patient (2687); Cerebral Edema (4403)

Event Date 09/04/2021

Event Type  Death  

Manufacturer Narrative

It is currently unknown if the complaint device will be returned for physical investigation.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, during a thrombectomy and using a micropuncture transitionless access set, a wire become retained in the patient.The patient had a large right middle cerebral artery occlusion.The procedure began successfully.Toward the end of the procedure, a piece of wire was retained.The patient was taken to the or and given 200u heparin.Postoperatively, the patient had a neurological deterioration.A head ct showed a large infarct, cerebral edema, and hemorrhage in the basal ganglia.As reported in the attached medwatch form (b)(4).Additional event details and patient outcome information has been requested.

Manufacturer Narrative

D10: concomitant products: canister penumbra engine nhpl aspiration neurovascular, sheath neuron introducer 6fr 90cm id.088in.035/.038in straight long crosscut valve rhv dilator max s/s ¿, angiocatheter reperfusion 6fr 132cm jet 7 std tip with aspiration tubingguidewire glidewire 260cm.035in 3cm standard angle flexible tip hydrophilic coated regular peripheral vascular bx/5ea, kit snare amplatz gooseneck 2.3-3frx 75cm 2mm 200cm vascular micro removal catheter 90degree coaxial loopvalve hemostatic 7fr.096in duostat rotating adjustable, set introducer micropuncture 5fr/10cm.018in/40cm 21g/7cm access transitionless tip nitinol wire platinum tip needle no baseplate wire guide coaxial catheter pair, set introducer micropuncture 5fr/10cm.018in/40cm 21g/7cm access transitionless tip nitinol wire platinum tip needle no baseplate wire guide coaxial catheter pair, guidewire fathom-16 10cm 180cm.016in embolization straight tip nitinol peripheral catheter angiography 5fr x 0.038in x 125cm tempo berenstein sidehole hydrophilic coated lf sterile disposable - discontinued per uom change use ps # 640999, microcatheter marksman 3.2/2.8fr 150cm 10cm.021in s/s infusion braided kink resistantintroducer sheath engage 8fr 12cm.035in vascular femoral, canister penumbra engine nhpl aspiration neurovascular , stent x soltaire 6mmx40mm trieversheath neuron introducer 6fr 90cm id.088in.035/.038in straight long crosscut valve rhv dilator max s/s, catheter reperfusion 6fr 132cm jet 7 std tip with aspiration tubing, guidewire glidewire 260cm.035in 3cm standard angle flexible tip hydrophilic coated regular peripheral vascular bx/5ea, kit snare amplatz gooseneck 2.3-3frx 75cm 2mm 200cm vascular micro removal catheter 90degree coaxial loop, valve hemostatic 7fr.096in duostat rotating adjustable, set introducer micropuncture 5fr/10cm.018in/40cm 21g/7cm access transitionless tip nitinol wire platinum tip needle no baseplate wire guide coaxial catheter pairset introducer micropuncture 5fr/10cm.018in/40cm 21g/7cm access transitionless tip nitinol wire platinum, tip needle no baseplate wire guide coaxial catheter pair, guidewire fathom-16 10cm 180cm.016in embolization straight tip nitinol peripheral, catheter angiography 5fr x 0.038in x 125cm tempo berenstein sidehole hydrophilic coated lf sterile disposable - discontinued per uom change use ps # 640999, microcatheter marksman 3.2/2.8fr 150cm 10cm.021in s/s infusion braided kink resistant, introducer sheath engage 8fr 12cm.035in vascular femoral the event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Information from the medwatch report was inadvertently omitted from the initial report.The complaint wire separated at the beginning of the procedure, as the user was obtaining access in the femoral artery.At the end of the procedure, vascular surgery was consulted and the patient was taken to surgery for retrieval of the wire.The patient received 2500 units of heparin during the retrieval procedure.Additional information was received on 05oct2021 that the femoral access site was not reported to be scarred or calcified, and resistance was not noted during insertion of the wire, at which point the wire separated.The complaint device was used to facilitate sheath placement.The retained wire fragment was removed during the retrieval procedure.Unfortunately, it was also reported that the patient has died.Additional information was received on 13oct2021 stating that the user cannot confirm if the wire was manipulated or removed through the access needle prior to separation.Tissue plasminogen activator (tpa) was given at outside hospital, prior to arrival to the facility in which the event took place.A bolus of 2500 units of heparin was given during the thrombectomy procedure.The patient's neurological status declined immediately after surgery to retrieve the wire fragment.The ct showed a right-sided stroke.It is unknown if the additional procedure related to the wire removal caused or contributed to the cerebral infarction/hemorrhage and subsequent death.

Manufacturer Narrative

Event summary: as reported, during a thrombectomy and using a micropuncture transitionless access set, a wire become retained in the patient.The patient had a large right middle cerebral artery occlusion.Tissue plasminogen activator (tpa) was given at an outside hospital, prior to arrival to the facility in which the event took place.The thrombectomy procedure began successfully before the device separated as the user was obtaining access in the femoral artery.The wire was retained in the patient.Vascular surgery was consulted, and the patient was taken to surgery for retrieval of the wire.The patient received (b)(4) units of heparin during the retrieval procedure.The patient's neurological status declined immediately after surgery to retrieve the wire fragment.Ct imaging showed large infarct, cerebral edema, and hemorrhage in the basal ganglia, and the patient subsequently died.It is unknown if the additional procedure related to the wire removal caused or contributed to the cerebral infarction/hemorrhage and subsequent death.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided instructions for use which caution, ¿do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt,¿ and, ¿withdrawal or manipulation of the distal spring coil portion of the mandril wire guide through a needle tip may result in breakage.¿ based on the available information, cook has concluded that a component failure unrelated to manufacturing or design deficiencies contributed to this event.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: MICROPUNCTURE TRANSITIONLESS ACCESS SET
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 12566588
• MDR Text Key: 274442984
• Report Number: 1820334-2021-02273
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002438705
• UDI-Public: (01)00827002438705(17)240723(10)14107185
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G43870
• Device Catalogue Number: MPIS-501-NT-SST
• Device Lot Number: 14107185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STENT X SOLTAIRE 6MMX40MM TRIEVER.
• Patient Outcome(s): Hospitalization; Required Intervention; Other; Death
• Patient Age: 90 YR
• Patient Sex: Female
• Patient Race: White