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

Model Number	G29989
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
As reported, at the end of an unknown procedure, the check-flo side arm separated from a flexor ansel guiding sheath.The user noticed that a small amount of blood was leaking from the device, and then discovered that the connecting tube had separated from the hub.Because this occurred at the end of the procedure, the surgeon replaced the device with a shorter sheath.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information has been requested.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Summary of event: as reported, at the end of an unknown procedure, the check-flo side arm separated from a flexor ansel guiding sheath.The user noticed that a small amount of blood was leaking from the device, and then discovered that the connecting tube had separated from the hub.Because this occurred at the end of the procedure, the surgeon replaced the device with a shorter sheath.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, 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 clear tubing was pulled out of the check-flo valve on the sheath.There were no holes present in the tubing.A document-based investigation evaluation was performed.No related non-conformances were found on the complaint lot or subassembly lots, and there have been no other reported complaints for this lot number.The raw material lot for the check-flo valve assembly found one related complaint.A supplier investigation was conducted on the component lot and the supplier determined that there are sufficient inspections in place for this failure and that there were no issues found with the provided component.The supplier stated that from the supplied photos the clear tubing has evidence of adhesive showing this part was attached when distributed.The supplier has determined that there were no manufacturing issues detected and a root cause of the failure could not be determined.The instructions for use (ifu) states "remove the wire guide and dilator, then aspirate and flush through the sheath side-arm.¿ from the information provided upon review of the dmr, dhr, ifu, device evaluation, and supplier investigation, cook concluded that the device was manufactured to specification and no non-conforming devices exists in house or out in the field.Cook concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the available information and results of the investigation, cook has concluded that a component failure unrelated to manufacturing or design deficiencies contributed to this incident.The appropriate personnel have been notified and cook will continue to monitor for similar events.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
• 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: 17073686
• Report Number: 1820334-2023-00693
• Device Sequence Number: 6673326
• Product Code: DYB
• UDI-Device Identifier: 00827002299894
• UDI-Public: (01)00827002299894(17)250804(10)14877263
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2023

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: 08/04/2025
• Device Model Number: G29989
• Device Catalogue Number: KCFW-6.0-18/38-90-RB-ANL1-HC
• Device Lot Number: 14877263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2022
• 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
• Patient Sex: Unknown