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

Model Number	G29981
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 an unknown procedure, a flexor ansel guiding sheath separated at the hub.Blood loss was reported; however, it is unknown if any intervention was required to treat blood loss.The physician was able to remove the device.Additional information has been requested.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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 (b)(6) 2021.The event occurred during an angiogram.The hub separated as the user removed the device from the groin by pulling on the hub.The dilator and a wire guide were in the sheath lumen.The anatomy was not tortuous, scarred, or calcified and resistance was not encountered."a little" blood loss was reported; however, there was no intervention taken to treat blood loss.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary as reported, during an angiogram, a flexor ansel guiding sheath separated at the hub.The hub separated as the user removed the device from the groin by pulling on the hub.The dilator and a wire guide were in the sheath lumen.The anatomy was not tortuous, scarred, or calcified and resistance was not encountered."a little" blood loss was reported; however, there was no intervention taken to treat blood loss.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, instructions for use, manufacturing instructions, and quality control procedures and a visual inspection of the device were conducted during the investigation.One used (b)(6) was received for investigation.The hub was separated from the sheath.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 with instructions for use which warn, ¿reinsertion of dilator prior to removal of flexor sheath increases the strength of the sheath and lessens the risk of device separation.¿ the ifu also instructs the user when removing the sheath to, ¿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 a component failure contributed to this 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: 12740670
• Report Number: 1820334-2021-02430
• Device Sequence Number: 17283174
• Product Code: DYB
• UDI-Device Identifier: 00827002299818
• UDI-Public: (01)00827002299818(17)240720(10)14099016
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2022

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: 07/20/2024
• Device Model Number: G29981
• Device Catalogue Number: KCFW-5.0-18/38-45-RB-ANL1-HC
• Device Lot Number: 14099016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 12/01/2021; 02/23/2022
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 12/08/2021; 03/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2021
• 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
• Patient Sex: Unknown