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

Model Number	G11636
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	02/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, upon completion of an angiogram, the hub separated from a flexor raabe guiding sheath upon removal of the device from the patient.Contralateral access was obtained in the left groin to target the right superficial femoral artery (sfa).The access site was not scarred, and the bifurcation was not steep or calcified.Per the reporter, ¿some¿ calcification was noted in the sfa.Another manufacturer¿s laser atherectomy device was used through the sheath, as well as an unspecified cook balloon and an unknown drug-coated balloon.Resistance was not encountered during insertion or removal of the sheath, nor upon insertion or removal of any device through the sheath.The dilator was not reinserted prior to removal of the sheath over an unknown wire guide.The sheath hub was used to pull the sheath from the patient, at which point the hub separated.The sheath shaft was removed endovascularly.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures or experience any adverse effects due to this event.
Additional Manufacturer Narrative
H3: device evaluation anticipated, but not yet begun.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, upon completion of an angiogram, the hub separated from a flexor raabe guiding sheath upon removal of the device from the patient.Contralateral access was obtained in the left groin to target the right superficial femoral artery (sfa).The access site was not scarred, and the bifurcation was not steep or calcified.Per the reporter, ¿some¿ calcification was noted in the sfa.Another manufacturer¿s laser atherectomy device was used through the sheath, as well as an unspecified cook balloon and an unknown drug-coated balloon.Resistance was not encountered during insertion or removal of the sheath, nor upon insertion or removal of any device through the sheath.The dilator was not reinserted prior to removal of the sheath over an unknown wire guide.The sheath hub was used to pull the sheath from the patient, at which point the hub separated.The sheath shaft was removed endovascularly.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures or experience any adverse effects due to this event.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.The hub was separated from the sheath, with no sheath material remaining in the hub.A section of the sheath was compressed at approximately 1.5-centimeters from the flare.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 states "avoid applying traction to the hub during removal.If resistance is anticipated or encountered during withdrawal of the flexor sheath, consider reinserting the dilator and removing the sheath and dilator as a unit.¿ 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 unintended user error contributed to this event, as the dilator was not reinserted prior to removal of the sheath, and the sheath hub was used to pull the sheath from the patient.The ifu states ¿avoid applying traction to the hub during removal.If resistance is anticipated or encountered during withdrawal of the flexor sheath, consider reinserting the dilator and removing the sheath and dilator as a unit.¿ 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: 21547806
• Report Number: 1820334-2025-00229
• Device Sequence Number: 17925538
• Product Code: DYB
• UDI-Device Identifier: 00827002116368
• UDI-Public: (01)00827002116368(17)271125(10)16355554
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/01/2025

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: G11636
• Device Catalogue Number: KCFW-6.0-38-70-RB-RAABE
• Device Lot Number: 16355554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PHILIPS LASER ARTHERECTOMY.
• Patient Sex: Female