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

Catalog Number	KCFW-8.0-38-40-RB-BLKN
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to patient contact during a cross over procedure, a flexor balkin guiding sheath's hub disconnected.The dilator was not advancing in the sheath and while trying to retrieve the dilator from the sheath, the hub of the sheath disconnected.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1: phone: 1800 22 1166.Postal code: (b)(6).H3: the 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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, prior to patient contact during a cross over procedure, a flexor balkin guiding sheath's hub disconnected.The dilator was not advancing in the sheath and while trying to retrieve the dilator from the sheath, the hub of the sheath disconnected.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, specifications, and quality control procedures were conducted during the investigation.A visual inspection and dimensional verification of the complaint device was also conducted.The complaint device was returned to cook for investigation.The sheath had pulled free from the hub.The dilator measured within specification; however, the sheath hub measured out of specification.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the lot.A review of complaint history found no additional complaints for this lot number.Cook investigated all lots manufactured by the same personnel, during the same week, as the complaint device.No relevant non-conformances or additional complaints were found on any of the lots.The customer followed relevant instructions in the ifu (instructions for use).A review of the device master record (dmr) 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.Cook has determined this to be an isolated event.Based on the information provided and the results of the investigation, cook has concluded that manufacturing and quality control deficiencies contributed to this event.The risk analysis for this failure mode was reviewed and no additional escalation was 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 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: 18970905
• Report Number: 1820334-2024-00413
• Device Sequence Number: 6299733
• Product Code: DYB
• UDI-Device Identifier: 00827002103856
• UDI-Public: (01)00827002103856(17)251010(10)15002237
• 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,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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: 10/10/2025
• Device Catalogue Number: KCFW-8.0-38-40-RB-BLKN
• Device Lot Number: 15002237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• 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: 71 YR
• Patient Sex: Female