MAUDE Adverse Event Report: COOK INC FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH; DYB INTRODUCER, CATHETER

Catalog Number	KCFW-12.0-35-45-RB-HFANL0-HC
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	09/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during an unknown procedure, the dilator hubs separated from two flexor high-flex ansel guiding sheaths.Reportedly, after inserting the sheath and dilator, the "injection piece" broke when the user pulled the dilator from the sheath.The dilators were removed with a clamp.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1: customer name and address = (b)(6).E3: occupation = purchasing 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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an unknown procedure, the dilator hubs separated from two flexor high-flex ansel guiding sheaths.Reportedly, after inserting the sheath and dilator, the "injection piece" broke when the user pulled the dilator from the sheath.The dilators were removed with a clamp.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information was received 19oct2023.The user confirmed that the "injection piece" was the hub.The dilator was not difficult to insert into the sheath.The access site was not scarred.Resistance was not encountered upon insertion or removal of the device.No part of the device was left in the patient.Investigation evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, specifications, and quality control procedures were conducted during the investigation.A visual inspection, dimensional verification, and functional test of one used complaint device and one sealed, unused device, was also conducted.One used complaint device was returned to cook for investigation, as well as one sealed, unused device.The used dilator was separated from the hub, with no shaft material remaining in the hub.There was slight evidence of the flare being present on the dilator shaft, consistent with the shaft being pulled through the hub at the time of separation.The dilator was inserted through the sheath; resistance was not encountered.The device measured within specification.The sealed device was opened, and a pull test was performed.The hub did not pull free from the unused dilator.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 relevant complaints for this lot number.Cook investigated all lots checked by the same personnel during the same week as the complaint lot.One relevant non-conformance was noted on one device from another lot; however, the device was scrapped.There have been no reported complaints on any of the lots.Responsible personnel were notified.The information provided upon review of the dmr, dhr, ifu, and investigation of the used 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.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that a quality control deficiency 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.
Additional Manufacturer Narrative
Additional information: b5, d9, 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
Additional information was received 19oct2023.The user confirmed that the "injection piece" was the hub.The dilator was not difficult to insert into the sheath.The access site was not scarred.Resistance was not encountered upon insertion or removal of the device.No part of the device was left in the patient.

• Brand Name: FLEXOR HIGH-FLEX ANSEL 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: 17745524
• Report Number: 1820334-2023-01238
• Device Sequence Number: 4160917
• Product Code: DYB
• UDI-Device Identifier: 00827002562790
• UDI-Public: (01)00827002562790(17)250222(10)14551652
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2023

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: 02/22/2025
• Device Catalogue Number: KCFW-12.0-35-45-RB-HFANL0-HC
• Device Lot Number: 14551652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 10/19/2023; 12/01/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 10/27/2023; 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2022
• 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