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

Model Number	G49043
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	11/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E3: occupation - supply specialist.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.
Event or Problem Description
As reported, during a fenestrated endovascular aortic repair (fevar) procedure, a flexor high-flex ansel guiding sheath's hub separated.Access was obtained at the left common femoral artery.The patient's anatomy was tortuous, calcified.And/or scarred; therefore, another manufacturer's 18 french sheath was in place.Another manufacturer's catheter was also used with the sheath.Upon removal of the complaint device over a cook wire "with very little tension/resistance", the hub separated.The hub was used to remove the sheath; however, there was "plenty of room" within the 18 french sheath and did not cause any resistance/drag that would have affected the tension.The dilator was not in place upon removal of the sheath.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures or experience any adverse effects due to the occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable or unchanged.Additional information: b5.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.
Event or Problem Description
Additional information was received on 09dec2024 stating that the shaft of the sheath was manually removed from the patient and that there was no sheath material left inside the sheath hub after separation.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable or unchanged.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.
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
Summary of event: as reported, during a fenestrated endovascular aortic repair (fevar) procedure, a flexor high-flex ansel guiding sheath's hub separated.Access was obtained at the left common femoral artery.The patient's anatomy was tortuous, calcified, and/or scarred; therefore, another manufacturer's 18 french sheath was in place.Another manufacturer's catheter was also used with the sheath.Upon removal of the complaint device over a cook wire "with very little tension/resistance", the hub separated.The hub was used to remove the sheath; however, there was "plenty of room" within the 18 french sheath and did not cause any resistance/drag that would have affected the tension.The dilator was not in place upon removal of the sheath.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures or experience any adverse effects due to the occurrence.Additional information was received on 09dec2024 stating that the shaft of the sheath was manually removed from the patient and that there was no sheath material left inside the sheath hub after separation.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.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.The product ifu states ¿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.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.¿ 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, and ifu suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that the patient¿s tortuous/calcified anatomy 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.

• 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: 20799527
• Report Number: 1820334-2024-01565
• Device Sequence Number: 6933212
• Product Code: DYB
• UDI-Device Identifier: 00827002490437
• UDI-Public: (01)00827002490437(17)270805(10)16190387
• 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
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/08/2025

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 Model Number: G49043
• Device Catalogue Number: KCFW-7.0-35-55-RB-HFANL1-HC
• Device Lot Number: 16190387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 12/09/2024; 01/17/2025; 04/15/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 12/16/2024; 01/21/2025; 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2024
• 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: 18FR DRYSEAL FLEX INTRODUCER SHEATH.; 7FR APTUS CATHETER.; ROSEN WIRE 260.
• Patient Age: 76 YR
• Patient Sex: Male