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

Model Number	G49045
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	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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 an endovascular intervention procedure, a flexor high-flex ansel guiding sheath's hub separated upon removal.Contralateral access was obtained via the left common femoral artery.The access site was not scarred, and the anatomy was not tortuous or calcified.The bifurcation angle was not steep/acute or calcified.The hub was used to remove the sheath over an unspecified wire guide and the check-flo valve broke off.The dilator was attempted to be inserted after separation of the hub, however, was unsuccessful.The sheath was removed endovascularly with "no damage or injury to the patient".Per the user, removal/insertion "didn't feel right", however "not so much that they were concerned about using it".A section of the device did not remain inside the patient.The patient did not require any additional procedures or experience any adverse effects due to the occurrence.Upon preliminary inspection of the returned device showed the check-flo hub separated from the sheath with no shaft material left in the cap.Multiple kinks were noted on the shaft of the sheath.
Additional Manufacturer Narrative
Summary of event: as reported, during an endovascular intervention procedure, a flexor high-flex ansel guiding sheath's hub separated upon removal.Contralateral access was obtained via the left common femoral artery.The access site was not scarred, and the anatomy was not tortuous or calcified.The bifurcation angle was not steep/acute or calcified.The hub was used to remove the sheath over an unspecified wire guide and the check-flo valve broke off.The dilator was attempted to be inserted after separation of the hub, however, was unsuccessful.The sheath was removed endovascularly with "no damage or injury to the patient".Per the user, removal/insertion "didn't feel right", however "not so much that they were concerned about using it".A section of the device did not remain inside the patient.The patient did not require any additional procedures or experience any adverse effects due to the occurrence.Upon preliminary inspection of the returned device showed the check-flo hub separated from the sheath with no shaft material left in the cap.Multiple kinks were noted on the shaft of the sheath.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.The check-flo hub was separated from the sheath, without any sheath material left in the cap.The sheath flare was not damaged.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 warns ¿reinsertion of dilator prior to removal of flexor sheath increases the strength of the sheath and lessens the risk of device separation.If resistance is anticipated or encountered during withdrawal of flexor sheath, consider carefully reinserting the dilator prior to continuing removal.¿ the ifu also states ¿remove the sheath.Avoid applying traction to 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.¿ 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, ifu, and investigation of the returned device 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 unintended user error contributed to this event.The dilator was not inserted prior to attempted removal to lessen the risk of sheath or hub separation, as instructed in the ifu.The sheath hub was also used to pull the sheath from the patient, which is warned against in the ifu.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.

• 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: 19360427
• Report Number: 1820334-2024-00691
• Device Sequence Number: 12347888
• Product Code: DYB
• UDI-Device Identifier: 00827002490451
• UDI-Public: (01)00827002490451(17)260918(10)15661129
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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: 09/18/2026
• Device Model Number: G49045
• Device Catalogue Number: KCFW-8.0-35-55-RB-HFANL1-HC
• Device Lot Number: 15661129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: "PENUMBRA PRODUCTS"
• Patient Sex: Unknown