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

Model Number	G11633
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: technologist.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during an unknown procedure a flexor raabe guiding sheath was being removed over a j wire when the hub separated from the sheath.The device was left indwelling in patient overnight and was removed the following morning.As the user removed the device, the hub separated from the sheath.The patient bled an unspecified amount after the hub separated, and the remainder of the device was removed from the patient.Another device was not required, as the procedure was complete.No adverse effects to the patient have been reported.Additional event details have been requested.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Event summary as reported, during an unknown procedure a flexor raabe guiding sheath was being removed over a j wire when the hub separated from the sheath.The device was left indwelling in patient overnight and was removed the following morning.As the user removed the device, the hub separated from the sheath.The patient bled an unspecified amount after the hub separated, and the remainder of the device was removed from the patient.Another device was not required, as the procedure was complete.No adverse effects to the patient have been reported.Investigation - evaluation a document-based investigation was performed including a review of complaint history, device history record, manufacturing instructions, quality control data, and the instructions for use (ifu).The complainant did not return the complaint device to cook for investigation.In response to this incident, cook reviewed the device history record.The dhr for the reported complaint device lot number records no non-conformances.A database search for complaints on the reported lot found no additional complaints reported from the field.Cook concluded that no nonconforming product from this lot exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warnings: ¿if resistance is encountered during advancement of the flexor sheath, assess cause of resistance and consider dilation of any restriction identified or consider alternate treatment strategy.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.Potential adverse events: ¿bleeding¿ sheath removal: 1.Insert a wire guide until its tip extends at least 10cm past the tip of the sheath.2.Remove the sheath.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.3.Remove the wire guide.Cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No new patient or event information since the last report was submitted.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Information provided 04nov2021 did not change the results of the investigation.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
Additional information was received 04nov2021.Access was obtained in the right femoral artery.An unspecified j wire and support catheter were used through the sheath during the procedure.The patient had calcified iliofemoral disease.The dilator was not in place upon removal of the device from the left iliofemoral region into the descending aorta and was not in place when the hub separated, nor was any other device in the lumen of the sheath at the time of the event.It is unknown if the hub was used to pull the sheath from the patient and unknown if resistance was encountered during insertion or removal of the sheath.No additional interventions were required.

• 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: 12252361
• Report Number: 1820334-2021-01897
• Device Sequence Number: 5128040
• Product Code: DYB
• UDI-Device Identifier: 00827002116337
• UDI-Public: (01)00827002116337(17)221017(10)10090145
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2021

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: 10/17/2022
• Device Model Number: G11633
• Device Catalogue Number: KCFW-7.0-38-55-RB-RAABE
• Device Lot Number: 10090145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 10/25/2021; 11/04/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 10/26/2021; 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2019
• 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 Age: 66 YR
• Patient Sex: Female
• Patient Weight: 81 KG