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

Catalog Number KCFW-5.0-18/38-45-RB-ANL1-HC

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/14/2021

Event Type  Injury  

Manufacturer Narrative

It is unknown if the device will be returned.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during an unknown procedure, a flexor ansel guiding sheath separated in the patient's artery.Bilateral femoral cut-down dissections were performed to remove the device from the patient.Additional information has been requested, but is not available at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.D10: concomitant products- two 3 x 220 mm sterling balloons, amplatz super stiff wire (boston) - (b)(6) 2021.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 Description

Additional information was received 25feb2021.Access was obtained in the left common femoral artery for angioplasty of the right lower extremity.Two balloons were utilized through the sheath for angioplasty of the right anterior tibial and right popliteal arteries.The sheath, which had been in place for approximately two hours, separated upon removal of the device after completion of the successful angioplasty, despite the user attempting multiple unspecified maneuvers to prevent the fracture.The hub of the device fractured first, and the distal fifteen centimeters of the device separated at the shaft.The aortic bifurcation was calcified but not hostile.Catheterization of the contralateral lower extremity was not difficult.Minimal resistance was encountered.Another manufacturer¿s wire was in the lumen of the sheath at the time of separation; however, the dilator was not in place at the time of removal or separation of the sheath.The entire sheath was removed via bilateral femoral artery cut-downs.The patient recovered uneventfully.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: b5, d9, h3.Summary of event: as reported, during an unknown procedure, a flexor ansel guiding sheath separated in the patient's artery.Bilateral femoral cut-down dissections were performed to remove the device from the patient.Additional information was received (b)(6) 2021.Access was obtained in the left common femoral artery for angioplasty of the right lower extremity.Two balloons were utilized through the sheath for angioplasty of the right anterior tibial and right popliteal arteries.The sheath, which had been in place for approximately two hours, separated upon removal of the device after completion of the successful angioplasty, despite the user attempting multiple unspecified maneuvers to prevent the fracture.The hub of the device fractured first, and the distal fifteen centimeters of the device separated at the shaft.The aortic bifurcation was calcified but not hostile.Catheterization of the contralateral lower extremity was not difficult.Minimal resistance was encountered.Another manufacturer¿s wire was in the lumen of the sheath at the time of separation; however, the dilator was not in place at the time of removal or separation of the sheath.The entire sheath was removed via bilateral femoral artery cut-downs.The patient recovered uneventfully.Investigation evaluation: reviews of the complaint history, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications were conducted during the investigation.The complaint device was not returned to cook for investigation.A device master record (dmr) review was performed, and device drawings, specifications, and quality control procedures associated with the complaint were identified.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The customer did not provide a lot for investigation.A database search of all lots sold to the customer in the past 3 years could not determine the affected lot.Due to this, cook could not complete a review of the device history record (dhr) or a database search for additional complaints reported from the field.The device's design history files (dhf) were reviewed, and the risks associated with these devices are acceptable when weighed against the benefits.Cook also reviewed the device instructions for use (ifu).It 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.¿ from the information provided upon review of the dmr, dhr, dhf, and ifu, cook could not conclude that the device was not manufactured to specification, or that there are nonconforming devices in house or out in the field.Based on the information provided and the results of the investigation, cook has concluded that an unintended user error and patient anatomy contributed to the failure mode.The physician stated that the anatomy was calcified, and the dilator was not reinserted prior to removal.The risk analysis for this failure mode was reviewed and no additional escalation was required.There is currently a capa investigation open to investigate this product failure.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 Description

Information was received (b)(6) 2021 that the device will not be returned to cook.

Manufacturer Narrative

A medwatch user report was received on 10jun2021 and has been attached to this report.Additional information the date of event has been updated per information in the medwatch report.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 Description

A medwatch report was received 10jun2021.No new patient or event information to report.

Manufacturer Narrative

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 Description

Photos were provided by the customer on 11aug2021.Photos show separation of the device below the hub as well as at three places along the shaft, with coils exposed.

• Brand Name: FLEXOR ANSEL GUIDING SHEATH
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11322969
• MDR Text Key: 231649892
• Report Number: 1820334-2021-00323
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: KCFW-5.0-18/38-45-RB-ANL1-HC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention