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

Model Number	G56233
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	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during a popliteal covered stent procedure the hub of a flexor high-flex ansel guiding sheath fell off.Access was gained via the right femoral artery and the groin was noted to be scarred.The sheath was advanced to the left femoral artery.The stent was placed without issue.As the sheath was being removed over a wire the hub fell off.The user then used clamps to removed the rest of the device.No portion of the device was left in the patient.The patient did not require any additional procedures or prolonged hospitalization.The patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
Information was available and inadvertently omitted from the initial report.Resistance was encountered upon both insertion and removal of the device.The dilator was not reinserted prior to removal of the sheath, and was not in place at the time of hub separation.Blood loss was not reported.
Additional Manufacturer Narrative
Summary of event: as reported, during a popliteal covered stent procedure the hub of a flexor high-flex ansel guiding sheath fell off.Access was gained via the right femoral artery and the groin was noted to be scarred.The sheath was advanced to the left femoral artery.Resistance was encountered upon both insertion and removal of the device.The dilator was not reinserted prior to removal of the sheath and was not in place at the time of hub separation.Blood loss was not reported.The stent was placed without issue.As the sheath was being removed over a wire the hub fell off.The user then used clamps to remove the rest of the device.No portion of the device was left in the patient.The patient did not require any additional procedures or prolonged hospitalization.The patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.The complaint device was not returned; however, a photo provided by the customer shows that the hub separated with the flare intact.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.Evidence from the complaint file, device history record, complaint history, device master record, and manufacturing documents suggests that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.The product ifu instructs the user to inspect the product to ensure no damage has occurred upon removal from the package and to avoid applying traction to the hub.The ifu also says that advancement of the sheath through resistance will increase the risk of sheath or hub separation upon withdrawal, and suggests reinsertion of the dilator prior to removal if resistance is anticipated or encountered upon withdrawal of the device.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that the patient¿s anatomy and user error contributed to the 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
• MDR Report Key: 11821912
• Report Number: 1820334-2021-01332
• Device Sequence Number: 19735557
• Product Code: DYB
• UDI-Device Identifier: 00827002562332
• UDI-Public: (01)00827002562332(17)230317(10)13059464
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2021

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: 03/17/2023
• Device Model Number: G56233
• Device Catalogue Number: KCFW-8.0-35-55-RB-HFANL0-HC
• Device Lot Number: 13059464
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VIABAHN COVERED STENT