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

Model Number G49099

Device Problems Fitting Problem (2183); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2021

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Occupation: lab manager.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 the stenting of the right superficial femoral artery via left groin access, the check-flo valve of a flexor ansel guiding sheath came apart twice during the procedure while inserting a stent graft system through the device.The user held the stent at the body of the device and not by the valve.The device was in place for about 15 minutes.There was no tortuous, scarred, or calcified anatomy noted.The patient experienced minimal blood loss, but did not require any intervention.A different manufacturer's device was used to complete the procedure.The patient was moved to recovery, and the patient's outcome was reported as "good".No unintended section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Correction- the summary report designation is incorrect; the report is not a summary report.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 Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Event summary as reported, during the stenting of the right superficial femoral artery via left groin access, the check-flo valve of a flexor ansel guiding sheath came apart twice during the procedure while inserting a stent graft system through the device.The user held the stent at the body of the device and not by the valve.The device was in place for about 15 minutes.There was no tortuous, scarred, or calcified anatomy noted.The patient experienced minimal blood loss but did not require any intervention.A different manufacturer's device was used to complete the procedure.The patient was moved to recovery, and the patient's outcome was reported as "good".No unintended section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.Investigation - evaluation reviews of the complaint history, device history record, instructions for use, drawing, manufacturing instructions, and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.Accordingly, no physical examination could be performed.A document-based investigation evaluation was performed.No related non-conformances were recorded, and no additional lot-related complaints were received.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.No gaps were identified in the device manufacturing instructions or quality control procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which warn, ¿if resistance is encountered during advancement of flexor sheath, assess cause of resistance and consider dilation of any restriction identified or consider alternate treatment strategy.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.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 further cautions, ¿in order to ensure device compatibility, choose a sheath size large enough to accommodate the maximum outer diameter of any devices that will be placed through the sheath.All interventional or diagnostic instruments used with this product should move freely through the valve and sheath to avoid damage.¿ based on the available information, cook has concluded that a component failure contributed to this incident.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.

• 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: 11395141
• MDR Text Key: 234431700
• Report Number: 1820334-2021-00865
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002490994
• UDI-Public: (01)00827002490994(17)231026(10)13512798
• Combination Product (y/n): N
• PMA/PMN Number: K142829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2023
• Device Model Number: G49099
• Device Catalogue Number: KCFW-8.0-18/38-45-RB-ANL0-HC
• Device Lot Number: 13512798
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TOURUS STENT GRAFT SYSTEM.