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

Model Number	G48189
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter occupation: catheterization lab manager.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during a tibial intervention, a flexor ansel guiding sheath stretched and broke, exposing coils as it was being removed.Access was gained through the "normal site" to reach a chronic total occlusion in the tibial artery, but the attempt to pass the lesion was unsuccessful and the procedure was aborted.The anatomy was noted to be calcified.As the user removed the sheath with the dilator in place it stretched and broke near the device tip, which exposed the coils.The patient's outcome was "good".No portion of the device was left within the patient.This did not result in any additional procedures or prolonged hospitalization.No adverse effects to the patient were reported to occur due to this event.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary as reported, during a tibial intervention, a flexor ansel guiding sheath stretched and broke, exposing coils as it was being removed.Access was gained through the "normal site" to reach a chronic total occlusion in the tibial artery, but the attempt to pass the lesion was unsuccessful and the procedure was aborted.The anatomy was noted to be calcified.As the user removed the sheath with the dilator in place it stretched and broke near the device tip, which exposed the coils.The patient's outcome was "good".No portion of the device was left within the patient.This did not result in any additional procedures or prolonged hospitalization.No adverse effects to the patient were reported to occur due to this event.Investigation - evaluation reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided instructions for use (ifu) which warn, ¿if resistance is encountered during advancement of flexor sheath, assess cause of resistance and consider dilation of any restriction identified or consider alternate treatment strategy.If flexor sheath is advanced through resistance, force to remove the sheath will be higher, increasing the risk of sheath material or hub separation upon withdrawal,¿ and, ¿reinsertion of dilator prior to removal of flexor sheath increases the strength of the sheath and lessens the risk of device separation.If resistance i anticipated or encountered during withdrawal of flexor sheath, consider carefully reinserting the dilator prior to continuing removal.¿ the ifu instructs regarding sheath removal, ¿remove the sheath.Avoid applying traction to the hub during removal.If resistance is anticipated or encountered during withdrawal of the flexor sheath, consider reinserting the dilator and removing the sheath and dilator as a unit.¿ based on the available information, cook has concluded that the patient¿s calcified anatomy likely contributed to the reported failure mode.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.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 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: 12569198
• Report Number: 1820334-2021-02276
• Device Sequence Number: 19839548
• Product Code: DYB
• UDI-Device Identifier: 00827002481893
• UDI-Public: (01)00827002481893(17)240706(10)14068827
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 01/10/2022

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: 07/06/2024
• Device Model Number: G48189
• Device Catalogue Number: KCFW-5.0-18/38-90-RB-ANL0-HC
• Device Lot Number: 14068827
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COOK 0.018" CXI CATHETER; HYDRO ST WIRE GUIDE; COOK 0.018" CXI CATHETER; HYDRO ST WIRE GUIDE
• Patient Sex: Male