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

Catalog Number	KCFW-5.0-18/38-45-RB-ANL1-HC
Medical Device Problem Codes	Break (1069); Stretched (1601); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during an angiogram of the right lower extremity, a flexor ansel guiding sheath unraveled and separated.Access was obtained in the left femoral artery and a contralateral approach was used to target the right femoral artery.The anatomy was very scarred, and the patient had a history of prior groin surgery.Resistance was encountered upon insertion of the sheath.Another manufacturer's catheter and wire guide were used during the procedure, as well as a cook wire.Upon successful completion of the procedure, resistance was encountered as the physician removed the sheath over an unspecified wire, by pulling the sheath hub.The dilator was not reinserted prior to sheath removal.The sheath separated below the hub; however, the user continued to pull on the sheath, which then began to unravel.The user then attempted to reinsert the dilator, but the dilator would not advance.The physician cut the "uncoiled part" and removed it from the wire guide.A 4-french catheter was then advanced through the undamaged part of the sheath.The wire was exchanged and the sheath and catheter were removed as a unit.Although the procedure was slightly delayed, there were no adverse effects to the patient as a result, and no additional procedures were required.No part of the device remained in the patient.Upon return and initial evaluation of the device, the sheath was unraveled, separated, and stretched.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E3: occupation - supervisor.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.
Additional Manufacturer Narrative
Summary of event: as reported, during an angiogram of the right lower extremity, a flexor ansel guiding sheath unraveled and separated.Access was obtained in the left femoral artery and a contralateral approach was used to target the right femoral artery.The anatomy was very scarred, and the patient had a history of prior groin surgery.Resistance was encountered upon insertion of the sheath.Another manufacturer's catheter and wire guide were used during the procedure, as well as a cook wire.Upon successful completion of the procedure, resistance was encountered as the physician removed the sheath over an unspecified wire, by pulling the sheath hub.The dilator was not reinserted prior to sheath removal.The sheath separated below the hub; however, the user continued to pull on the sheath, which then began to unravel.The user then attempted to reinsert the dilator, but the dilator would not advance.The physician cut the "uncoiled part" and removed it from the wire guide.A 4-french catheter was then advanced through the undamaged part of the sheath.The wire was exchanged, and the sheath and catheter were removed as a unit.Although the procedure was slightly delayed, there were no adverse effects to the patient as a result, and no additional procedures were required.No part of the device remained in the patient.Upon return and initial evaluation of the device, the sheath was unraveled, separated, and stretched.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), and 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 sheath was unraveled and separated just below the hub.The sheath was bunched approximately 34.1-centimeters from the distal end.Stretching and elongation were noted along several areas of the sheath, with the inner coils exposed.The sheath flare, which appeared undamaged, remained in the hub.A competitor¿s catheter was inside part of the sheath, and resistance was encountered when removing the competitor¿s device, which was damaged 25-centimeters from the hub.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 ¿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.¿ 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 at the time of manufacture.There is no evidence of non-conforming devices in-house or in the field.A previously closed capa found that the thin wall of the ptfe liner is susceptible to damage from handling and processing during profiling and coiling processes; leading to an increased susceptibility to shaft separation.Corrective actions were implemented, including 100% bond inspections, increase of the minimum allowable tensile strength, improvements to the baking process, and reduction in shelf life of inner liner raw material.The complaint device was manufactured prior to implementation of the corrective actions.Based on the information provided and the results of the investigation, cook has concluded that the patient¿s anatomy and a manufacturing deficiency contributed to this event; however, the complaint device was manufactured prior to implementation of corrective actions resulting from a previously completed capa.The anatomy was very scarred, and resistance was encountered upon insertion and removal of the sheath.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 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: 17995092
• Report Number: 1820334-2023-01432
• Device Sequence Number: 20319647
• Product Code: DYB
• UDI-Device Identifier: 00827002299818
• UDI-Public: (01)00827002299818(17)250502(10)14700617
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2024

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: 05/02/2025
• Device Catalogue Number: KCFW-5.0-18/38-45-RB-ANL1-HC
• Device Lot Number: 14700617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2023
• Supplement Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 0.035,180 BENSON WIRE; 4 FR CORDIS CATHETER; BOSTON SCIENTIFIC AMPLATZ SUPER STIFF 260CM
• Patient Age: 69 YR
• Patient Sex: Female