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

Model Number	G30009
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: clinical coordinator.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 angioplasty procedure, a flexor shuttle tibial guiding sheath separated at both the hub and shaft upon removal of the device.Access was obtained in the right femoral artery to target the tibial vessels.The right common iliac artery was reportedly heavily calcified, and the tibial vessels were described as having multi-level disease.The physician intended to stent the common iliac with an unknown stent; however, this was not possible, as the stent ¿would not come out¿.An unknown angioplasty balloon was used during the procedure.Resistance was encountered as the user attempted to remove the sheath; however, the dilator was not reinserted into the sheath.As the user pulled the sheath, the hub and sheath separated, leaving a portion of the sheath in the right femoral artery.The patient was taken to surgery for a cut-down procedure, and the separated portion of the sheath was removed.The patient was discharged the following day.Per the reporter, the patient has not experienced any adverse effects due to this event.
Event or Problem Description
No additional information has been received since the last report was submitted.
Additional Manufacturer Narrative
Summary of event: as reported, during an angioplasty procedure, a flexor shuttle tibial guiding sheath separated at both the hub and shaft upon removal of the device.Access was obtained in the right femoral artery to target the tibial vessels.The right common iliac artery was reportedly heavily calcified, and the tibial vessels were described as having multi-level disease.The physician intended to stent the common iliac with an unknown stent; however, this was not possible, as the stent ¿would not come out¿.An unknown angioplasty balloon was used during the procedure.Resistance was encountered as the user attempted to remove the sheath; however, the dilator was not reinserted into the sheath.As the user pulled the sheath, the hub and sheath separated, leaving a portion of the sheath in the right femoral artery.The patient was taken to surgery for a cut-down procedure, and the separated portion of the sheath was removed.The patient was discharged the following day.Per the reporter, the patient has not experienced any adverse effects due to this event.Investigation evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.A document-based investigation evaluation was performed.One relevant non-conformance was noted; however, affected product was scrapped and not replaced.No additional complaints have been received on other devices from this lot.The product 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 information provided upon review of the dmr, dhr, and ifu 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.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.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.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 SHUTTLE TIBIAL 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: 13868926
• Report Number: 1820334-2022-00440
• Device Sequence Number: 5296167
• Product Code: DYB
• UDI-Device Identifier: 00827002300095
• UDI-Public: (01)00827002300095(17)230824(10)13385267
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K142819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/24/2023
• Device Model Number: G30009
• Device Catalogue Number: KSAW-5.0-18/38-90-RB-SHTL-HC
• Device Lot Number: 13385267
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2022
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown