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

Model Number	G13091
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	05/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: device evaluated by mfg = 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, during an angiogram of the right lower extremity via contralateral access in the left groin to target the right distal popliteal artery, the hub of a flexor raabe guiding sheath separated.The access site was not scarred; however, the right distal popliteal artery was stenosed.The bifurcation was not steep or calcified.An unknown manufacturer¿s 0.035-inch ¿zip¿ wire was used during the procedure, and an unknown catheter and balloon were also used through the sheath.Resistance was not encountered during insertion or removal of the sheath or during insertion or removal of any device through the sheath.Upon removal of the sheath over the 0.035-inch wire, the hub separated from the device.The dilator was not reinserted prior to removal of the sheath, which was pulled by the hub and shaft.The sheath shaft was manually removed from the patient after the hub separated.A section of the device did not remain inside the patient¿s body.The patient, who is reportedly ¿ok¿, did not require any additional procedures or experience any adverse effects due to this event.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an angiogram of the right lower extremity via contralateral access in the left groin to target the right distal popliteal artery, the hub of a flexor raabe guiding sheath separated.The access site was not scarred; however, the right distal popliteal artery was stenosed.The bifurcation was not steep or calcified.An unknown manufacturer¿s 0.035-inch ¿zip¿ wire was used during the procedure, and an unknown catheter and balloon were also used through the sheath.Resistance was not encountered during insertion or removal of the sheath or during insertion or removal of any device through the sheath.Upon removal of the sheath over the 0.035-inch wire, the hub separated from the device.The dilator was not reinserted prior to removal of the sheath, which was pulled by the hub and shaft.The sheath shaft was manually removed from the patient after the hub separated.A section of the device did not remain inside the patient¿s body.The patient, who is reportedly ¿ok¿, did not require any additional procedures or experience any adverse effects due to this event.Corrected information: d4 = udi.Investigation evaluation: reviews of the complaint history, device history record (dhr), drawings, 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.The hub was separated from the sheath.No sheath material remained in the hub.The hub diameter measured within specification.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 relevant 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 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 the patient¿s anatomy and user error contributed to this event.The right distal popliteal artery was reportedly stenosed, and the dilator was not reinserted prior to sheath removal, to lessen the risk of sheath material or hub separation upon withdrawal.The ifu warns ¿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 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: 22212485
• Report Number: 1820334-2025-00713
• Device Sequence Number: 18179964
• Product Code: DYB
• UDI-Device Identifier: 00827002130913
• UDI-Public: (01)00827002130913(17)280324(10)16522901
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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: G13091
• Device Catalogue Number: KCFW-5.0-38-70-RB-RAABE
• Device Lot Number: 16522901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2025
• 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