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

Model Number	G13264
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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 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 or Problem Description
As originally reported, upon opening the package, the "hemostatic valve of the y valve" was missing from a flexor shuttle tibial guiding sheath.A photo provided by the customer shows only the stopcock, attached to the side-arm tubing.Another device was used to complete the procedure.There were no adverse effects to the patient.Upon return and initial evaluation of the device, it was discovered that the silicone disc/valve was missing from the tuohy-borst valve, which leaked during testing.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Summary of event: as originally reported, upon opening the package, the "hemostatic valve of the y valve" was missing from a flexor shuttle tibial guiding sheath.A photo provided by the customer shows only the stopcock, attached to the side-arm tubing.Another device was used to complete the procedure.There were no adverse effects to the patient.Upon return and initial evaluation of the device, it was discovered that the silicone disc/valve was missing from the tuohy-borst valve, which leaked during testing.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures were conducted during the investigation.A visual examination of the complaint device was also conducted.The complaint device was returned to cook for investigation.The hemostasis valve was missing from the tuohy-borst ¿y¿ connector.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.Cook also investigated all lots checked by the same personnel as the complaint lot.No relevant non-conformances or additional complaints were found on those lots.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that the complaint device was manufactured out of specification; however, cook has concluded that this is an isolated incident, as there were no related non-conformances or additional complaints on the lot, adequate inspection activities have been established, and there is objective evidence that the dhr was fully executed.There is no evidence of additional non-conforming product in-house or in the field.Based on the available information and results of the investigation, cook has concluded that a quality control deficiency contributed to the failure mode.The responsible personnel have been notified.The risk analysis for this failure mode was reviewed and no additional escalation is required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: FLEXOR SHUTTLE TIBIAL 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: 16863237
• Report Number: 1820334-2023-00539
• Device Sequence Number: 14902043
• Product Code: DYB
• UDI-Device Identifier: 00827002132641
• UDI-Public: (01)00827002132641(17)250912(10)14951005
• Combination Product (Y/N): N
• PMA/510(K) Number: K142819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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: 09/12/2025
• Device Model Number: G13264
• Device Catalogue Number: KSAW-6.0-38-90-RB-SHTL-HC
• Device Lot Number: 14951005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2022
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 78 KG