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

Model Number	G11638
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during the procedure and using a flexor raabe guiding sheath, the end of the sheath was noted to "ooze blood" or leak.The issue occurred during insertion of the device, and patient contact was confirmed.After the insertion through the femoral artery, and angiography was performed via the sheath during spinal surgery with the patient in the reverse position.The sheath was in place for about 25 minutes.The patient did not experience any blood loss.The procedure was completed by replacing with another new device of the same type.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 Manufacturer Narrative
(b)(6).A follow up report will be submitted should additional relevant information become available.
Additional Manufacturer Narrative
Summary of event: as reported, during the procedure and using a flexor raabe guiding sheath, the end of the sheath was noted to "ooze blood" or leak.The issue occurred during insertion of the device, and patient contact was confirmed.After the insertion through the femoral artery, and angiography was performed via the sheath during spinal surgery with the patient in the reverse position.The sheath was in place for about 25 minutes.The patient did not experience any blood loss.The procedure was completed by replacing with another new device of the same type.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), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection and functional test of the complaint device was also conducted.The complaint device was returned to cook for investigation.The device was leak tested with a syringe filled with water and a check-flo valve leak was confirmed.Cook reviewed the device history record (dhr).The dhr for the reported lot found 1 related non-conformance, however, the device was scrapped.A complaint history search was completed on the reported lot and found no additional complaints reported from the field.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.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: ¿using the side-arm of the value, flush the sheath by filling the sheath assembly completely with heparinized saline." how supplied ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ cook has concluded a component failure contributed to this failure mode.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.
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 RAABE 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: 12822155
• Report Number: 1820334-2021-02504
• Device Sequence Number: 14864702
• Product Code: DYB
• UDI-Device Identifier: 00827002116382
• UDI-Public: (01)00827002116382(17)240519(10)13970627
• Combination Product (Y/N): N
• PMA/510(K) Number: K142829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2022

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: 05/19/2024
• Device Model Number: G11638
• Device Catalogue Number: KCFW-6.0-38-55-RB-RAABE
• Device Lot Number: 13970627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2021
• 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