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

Model Number	G13069
Medical Device Problem Codes	Break (1069); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during an unknown procedure, a flexor raabe guiding sheath unraveled upon withdrawal from the patient.The sheath was manually removed from the patient after unraveling.An x-ray was performed to determine if any part of the device was left in the patient; however, nothing was found, and the user was reportedly satisfied that no part of the device remained in the patient.The patient did not require any additional procedures or experience any adverse effects due to this event.
Additional Manufacturer Narrative
E3: occupation = supply management.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.
Additional Manufacturer Narrative
Summary of event: as reported, during an unknown procedure, a flexor raabe guiding sheath unraveled upon withdrawal from the patient.The sheath was manually removed from the patient after unraveling.An x-ray was performed to determine if any part of the device was left in the patient; however, nothing was found, and the user was reportedly satisfied that no part of the device remained in the patient.The patient did not require any additional procedures or experience any adverse effects due to this event.Corrected information: h6 (annex a).Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, 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 in three sections.The proximal section¿s coil was exposed approximately 47.3-centimeters from the hub.The middle section measured approximately 1.8-centimeters in length, and coil was exposed on both ends.The distal section measured 43.7-centimeters from the distal tip, with coil exposed at the point of separation.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the lot.A review of complaint history found no additional complaints for this lot number.The product ifu warns ¿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.¿ the ifu also states ¿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.¿ a review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that a component failure contributed to this 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 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: 21036952
• Report Number: 1820334-2024-01697
• Device Sequence Number: 12670311
• Product Code: DYB
• UDI-Device Identifier: 00827002130692
• UDI-Public: (01)00827002130692(17)270918(10)16254774
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2025

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 Model Number: G13069
• Device Catalogue Number: KCFW-5.0-38-90-RB-RAABE
• Device Lot Number: 16254774
• 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: 12/17/2024
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2024
• 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