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

Model Number	G31138
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation = non-healthcare professional.Pma/510(k) number = k153430.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 placement of an unknown stent involving the carotid artery, a flexor shuttle select guiding sheath unraveled upon removal of the device.As the user attempted to exchange the sheath for an alternate approach, it unraveled at the end as it was pulled out.An unknown wire guide was utilized during the procedure.Details of the patient's anatomy are unknown.It is unknown if the dilator or any other device was in the lumen of the sheath at the time of the event.Resistance was not reported during insertion or removal of the device.The procedure was successfully completed with another sheath and the patient was reportedly stable.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Summary of event: as reported, during placement of an unknown stent involving the carotid artery, a flexor shuttle select guiding sheath unraveled upon removal of the device.As the user attempted to exchange the sheath for an alternate approach, it unraveled at the end as it was pulled out.An unknown wire guide was utilized during the procedure.Details of the patient's anatomy are unknown.It is unknown if the dilator or any other device was in the lumen of the sheath at the time of the event.Resistance was not reported during insertion or removal of the device.The procedure was successfully completed with another sheath and the patient was reportedly stable.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: a review of the instructions for use (ifu), manufacturing instructions, and quality control was conducted during the investigation.The complaint device was not returned; therefore, examination of the device was not possible.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The complaint file, device history record, complaint history, and manufacturing documents provide objective evidence to suggest that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.The quality control, manufacturing, and work instructions contain adequate measures to address the failure mode prior to distribution.The product labeling provides warnings and precautions for users related to the failure mode.There were no gaps identified in the manufacturing or quality control processes.The product ifu warns the user: "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 the 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 or flexor sheath, consider carefully reinserting the dilator prior to continuing removal." based on the information provided and the results of the investigation, cook has concluded that the cause for this event cannot be determined; however, based on the manufacturing review there is no evidence to suggest manufacturing issues were at fault.It is possible that anatomical factors or ancillary device interaction may have played a role in this failure; however, this cannot be confirmed as the details were unknown.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 SELECT GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9680977
• Report Number: 1820334-2020-00303
• Device Sequence Number: 3414729
• Product Code: DYB
• UDI-Device Identifier: 00827002311381
• UDI-Public: (01)00827002311381(17)220729(10)9911929
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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: 07/29/2022
• Device Model Number: G31138
• Device Catalogue Number: KSAW-6.0-38-90-RB-SHTL-FLEX-HC
• Device Lot Number: 9911929
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1