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

Model Number	G29989
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Occupation = lead tech.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, a flexor ansel guiding sheath's dilator was difficult to insert into the sheath and kinked during preparation of the device prior to patient contact.The user attempted to insert the dilator from both the hub and tip of the sheath but the dilator became caught midway through the sheath.Upon return and investigation of the complaint device, delamination was noted within the sheath.A section of the device did not remain inside the patient¿s body.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.
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
Event summary as originally reported, a flexor ansel guiding sheath's dilator was difficult to insert into the sheath and kinked during preparation of the device prior to patient contact.The user attempted to insert the dilator from both the hub and tip of the sheath but the dilator became caught midway through the sheath.Upon return and investigation of the complaint device, delamination was noted within the sheath.A section of the device did not remain inside the patient¿s body.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.Investigation ¿ evaluation.Reviews of the complaint history, device history record, drawing, instructions for use, manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection, dimensional verification and functional test of the complaint device was also conducted.The complaint device was returned to cook for investigation.The dilator would only go into the sheath hub approximately five centimeters.The inner diameter of the sheath and outer diameter of the dilator measured within specification.During table top testing, the hub was disassembled and broke/snapped off.The dilator was backloaded into the sheath, however, strong resistance was felt.Delamination was noted within the sheath.Cook completed a review of the device history record (dhr).The dhr for the reported lot recorded no relevant non-conformances.A complaint history search of the complaint lot found six additional complaints from the field for the same failure.The component lots associated with the complaint lot found no relevant non-conformances.The subassembly lots were used in eleven other final lots and a complaint history search on these lots found no relevant non-conformances.Cook concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The instructions for use (ifu) states ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ the information provided upon review of the dmr, dhr, ifu, and investigation of the returned device provides evidence that this device was manufactured out of specification.However, cook believes this to be an isolated incident, and that no additional nonconforming product exists in-house or in the field.There are 100% inspections in place to capture this non-conformance prior to distribution.Based on the available information, cook has concluded that a quality control deficiency contributed to this event.The responsible personnel were retrained on 07dec2022.Per a review of risk documentation, no further action is required.Cook reviewed the occurrence rates for this failure mode and there is not an increase in the occurrence rate.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 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: 15895987
• Report Number: 1820334-2022-01796
• Device Sequence Number: 20510046
• Product Code: DYB
• UDI-Device Identifier: 00827002299894
• UDI-Public: (01)00827002299894(17)250526(10)14753855
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2023

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: 05/26/2025
• Device Model Number: G29989
• Device Catalogue Number: KCFW-6.0-18/38-90-RB-ANL1-HC
• Device Lot Number: 14753855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2022
• 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