MAUDE Adverse Event Report: COOK INC FLEXOR RTPS GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Codes	Unraveled Material (1664); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the valve of the flexor rtps guiding sheath separated during an inferior vena cava (ivc) filter placement on a 67 year-old patient.The physician inserted the sheath over the wire guide.During removal of the introducer from the sheath, the valve of the sheath detached from the sheath.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
E3 - occupation: physician service rep.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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
Upon device failure analysis of the returned complaint device, it was determined the sheath unraveled.The sheath appeared to be pulled through the hub with the dilator and the coils of the sheath were exposed.No other damage was noted.
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 unchanged, unknown, or unavailable.Correction: h6 - annex a investigation ¿ evaluation it was reported the valve of the flexor rtps guiding sheath separated during an inferior vena cava (ivc) filter placement.The physician inserted the sheath over the wire guide.During removal of the introducer from the sheath, the valve of the sheath detached from the sheath.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, quality control procedures, and specifications, as well as a visual inspection, functional test, and dimensional verification of the returned device, were conducted during the investigation.One used sheath was received.Upon examination, the sheath was pulled through the hub with the dilator.The sheath and flare appeared to have turned "inside out" and folded in on itself.The flare was damaged.The inner coils of the sheath were exposed.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the device history record (dhr) for the complaint lot.There is one additional complaint on this lot reported for sheath hub separation.It is unrelated to the reported failure.There is a nonconformance on this lot, however it is unrelated to the reported failure.An expanded dhr was performed.Additional lots of the same rpn which were manufactured within 1 month of the complaint lot were reviewed.72 additional lots were found.No related complaints were found.There were 29 related nonconformances from these lots that were found.All nonconforming devices have been scrapped or reworked.All remaining devices have been inspected 100%.A project is open to investigate related nonconformances that were found.The information provided upon review of the returned device indicates the device was manufactured out of specification.However, review of the device master record, device history record, and ifu, suggests that there are no additional nonconforming devices in house or in the field.Cook also reviewed product labeling.The product ifu, [t_flexor_rev2] ¿flexor introducer / flexor guiding sheath,¿ provides the following information to the user related to the reported failure mode: ¿warnings -if resistance is encountered during advancement of flexor sheath, assess cause f resistance and consider dilation of any restriction identified or consider alternate treatment strategy.If flexor sheath is advanced through resistance, force to remove the sheath will be higher, increasing the risk of sheath material or hub separation upon withdrawal.¿ based on the information provided, inspection of the returned device, and the results of the investigation, it was determined the cause of this event is related to manufacturing and quality control deficiencies.Complaint awareness notifications were issued and acknowledged by the responsible personnel.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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: FLEXOR RTPS GUIDING SHEATH
• Common Device Name: 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: 17438104
• Report Number: 1820334-2023-01000
• Device Sequence Number: 21061160
• Product Code: DYB
• UDI-Device Identifier: 00827002130814
• UDI-Public: (01)00827002130814(17)250804(10)14877280
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2024

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: 08/04/2025
• Device Model Number: N/A
• Device Catalogue Number: KCFW-10.0-35-RB-RTPS-100
• Device Lot Number: 14877280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 08/08/2023; 01/09/2024
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 09/05/2023; 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2022
• 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
• Patient Age: 67 YR
• Patient Sex: Unknown