MAUDE Adverse Event Report: COOK INC TRIFORCE¿ PERIPHERAL CROSSING SET; KRA CATHETER, CONTINUOUS FLUSH

Model Number	G56419
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Initial reporter occupation: respiratory therapist.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during a venous occlusion procedure the tip of a triforce¿ peripheral crossing set sheared within the patient.The procedure was completed successfully.It was reported that the patient is doing well.No adverse effects to the patient have been reported.Additional information has been requested.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Corrected information: b5 h3: device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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 or Problem Description
Additional information was received (b)(6) 2021, but inadvertently not included in our initial report: as reported, there was nothing unusual about the patient/case.No piece of the device was left in the patient¿s body.The patient did not require any additional procedures due to this occurrence.The patient was not harmed in any way.A new device was used to complete the procedure.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary as reported, during a venous occlusion procedure the tip of a triforce¿ peripheral crossing set sheared within the patient.There was nothing unusual about the patient/case.No piece of the device was left in the patient¿s body.The patient did not require any additional procedures due to this occurrence.The patient was not harmed in any way.A new device was used to complete the procedure successfully.Investigation - evaluation reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures and a visual inspection of the device were conducted during the investigation.One used kcxs-5.0-35-100-rb-mpb/dav-hc was returned to cook for investigation.The cxi catheter was inserted into the blue sheath.The distal tip of the sheath was frayed.A document-based investigation evaluation was performed.Five non-conformances were recorded which are relevant to the reported failure mode; all non-conforming product was scrapped, and there are 100% inspections to capture this non-conformance.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 with instructions for use which provide the following information relevant to the reported failure mode: precautions ¿the device is designed and intended for one time use only.Do not re-sterilize and/ or reuse.¿device manipulation should only occur under fluoroscopy.¿ ¿the device should not be advanced into a vessel having a reference vessel diameter smaller than the sheath out diameter.¿ ¿the device should not be forced through an area of resistance unless the source of resistance is identified by fluoroscopy and appropriate steps are taken to reduce or remove the obstruction.¿ ¿due to its tapered design, the outer diameter of 4.0 french or smaller.¿ instructions for use ¿wet the entire surface of both sheath and the support catheter with heparinized saline solution or sterile water.This will activate the hydrophilic coating, making the surface of both devices lubricious.¿ ¿caution: be sure the wire guide tip is extended beyond the cxi support catheter tip at all times, and the cxi support catheter tip is extended beyond the flexor sheath tip at all times.¿ based on the available information, cook has concluded that a component failure contributed to this failure mode.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.

• Brand Name: TRIFORCE¿ PERIPHERAL CROSSING SET
• Common Device Name: KRA CATHETER, CONTINUOUS FLUSH
• 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: 12511939
• Report Number: 1820334-2021-02193
• Device Sequence Number: 3787622
• Product Code: KRA
• UDI-Device Identifier: 00827002564190
• UDI-Public: (01)00827002564190(17)230818(10)13342002
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K170931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2022

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: 08/18/2023
• Device Model Number: G56419
• Device Catalogue Number: KCXS-5.0-35-100-RB-MPB/DAV-HC
• Device Lot Number: 13342002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 11/03/2021; 01/11/2022
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 11/07/2021; 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2020
• 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
• Patient Sex: Unknown