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

Model Number	G10384
Medical Device Problem Codes	Peeled/Delaminated (1454); Contamination /Decontamination Problem (2895); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, while flushing the device prior to use for an unspecified procedure, the tip of a flexor balkin guiding sheath was noted to be "chapped".A new device was used to complete the procedure.There were no adverse effects to the patient.Photos provided by the customer show white material around the tip of the sheath and a split in the tip of the dilator.
Additional Manufacturer Narrative
Initial reporter's customer name and address = (b)(6).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.Additional/corrected information: b5, d9, h3, h6 (annex a and g) h3: (other): the device has been returned and a preliminary evaluation has been performed; however, the investigation is ongoing.A device evaluation summary will be included in a follow up report once the 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
Upon return and evaluation of the complaint device, the tip of the dilator was not split as originally reported.Additionally, the white material around the tip of the sheath is believed to be foreign matter/material.
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.Summary of event: as reported, while flushing the device prior to use for an unspecified procedure, the tip of a flexor balkin guiding sheath was noted to be "chapped".A new device was used to complete the procedure.There were no adverse effects to the patient.Photos provided by the customer were initially believed to show white material around the tip of the sheath and a split in the tip of the dilator.Upon return and evaluation of the complaint device, the tip of the dilator was not split as originally reported.Additionally, the white material around the tip of the sheath is believed to be foreign matter/material.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.Unknown white particles were noted on the distal end of the sheath.The dilator tip was folded inward, not split as originally reported.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other related complaints for this lot number.Cook investigated all lots manufactured by the same personnel, during the same week, as the complaint lot.No relevant non-conformances or additional complaints were found.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 there is evidence the device was manufactured out of specification; however, there is no evidence of additional non-conforming devices in-house or in the field.Responsible personnel have been notified.Based on the available information and results of the investigation, cook has concluded that a manufacturing deficiency contributed to this event.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.

• Brand Name: FLEXOR BALKIN 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: 16683767
• Report Number: 1820334-2023-00374
• Device Sequence Number: 7226105
• Product Code: DYB
• UDI-Device Identifier: 00827002103849
• UDI-Public: (01)00827002103849(17)250511(10)14724562
• Combination Product (Y/N): N
• PMA/510(K) Number: K142829
• 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,Followup
• Report Date (Section B): 08/02/2023

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: 05/11/2025
• Device Model Number: G10384
• Device Catalogue Number: KCFW-7.0-38-40-RB-BLKN
• Device Lot Number: 14724562
• 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: 03/13/2023
• Supplement Date Received by Manufacturer: 04/05/2023; 07/07/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 05/04/2023; 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2022
• 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 Sex: Unknown