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

Model Number	G31138
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: lead tech.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
It was reported, while attempting to place a carotid stent and using a flexor shuttle select guiding sheath, the wire could not pass through and the device broke in half inside of the patient.The user put it in the left carotid from the right femoral and attempted to advance a spider wire through it, but the wire would not pass through.It was initially thought the wire was malfunctioning.They attempted to use another spider wire, but this wire also would not pass through.It was then that they noticed the flexor was broken.They went to remove it, and at this time, it broke in half.The proximal part of the sheath remained inside of the patient.Vascular surgery came to perform a cutdown to remove the remaining portion of the device from the patient.They completed the procedure from the radial artery instead of the femoral as originally attempted.No adverse effects to the patient have been reported due to the alleged malfunction.Additional patient and event information has been requested.
Event or Problem Description
Additional information was provided on 09nov2020: the patient was noted to be recovering well with no lasting issues.The patient was noted to be a smoker but did not have scarred anatomy, nor tortuous or calcified vessels.Patient was here for common carotid stent for severe stenosis, however, sheath did not traverse stenosis.The event occurred mid-procedure and no dilator was in place.The separation occurred while working the device through the sheath.The sheath was removed without the dilator because a broken wire was trapped within the sheath.The wire broke because of the sheath defect and could not be removed separately for fear of dislodging in the brain.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: it was reported, while attempting to place a carotid stent and using a flexor shuttle select guiding sheath, the wire could not pass through and the device broke in half inside of the patient.The user put it in the left carotid from the right femoral and attempted to advance a spider wire through it, but the wire would not pas through.It was initially thought the wire was malfunctioning.They attempted to use another spider wire, but this wire also would not pass through.It was then that they noticed the flexor was broken.They went to remove it, and at this time, it broke in half.The proximal part of the sheath remained inside of the patient.Vascular surgery came to perform a cutdown to remove the remaining portion of the device from the patient.They completed the procedure from the radial artery instead of the femoral as originally attempted.Investigation ¿ evaluation a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, documentation, drawings, the instructions for use, manufacturing instructions, quality control data, and specifications.The complainant returned ksaw-6.0-38-90-rb-shtl-flex-hc used to cook for investigation.Physical examination of the returned device showed: one ksaw received used with biological material present.Inspection found the sheath is separated at 11.5cm from the distal end.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.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 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.¿ 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.Instructions for use sheath introduction 1.If the device has hydrophilic coating, activate the coating by wetting the outer surface of the device with heparinized saline.Note: for best results, maintain wetted condition of device during placement.How supplied upon removal from package, inspect the product to ensure no damage has occurred." capa 312547, con-2020-064, and far-2020-058 have been open and are ongoing in reaction to this issue.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Based on the provided evidence and the completed investigation, cook has concluded bond separation contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook 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 to report.

• 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: 10810705
• Report Number: 1820334-2020-02053
• Device Sequence Number: 14402485
• Product Code: DYB
• UDI-Device Identifier: 00827002311381
• UDI-Public: (01)00827002311381(17)230720(10)13315288
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/19/2021

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: 07/20/2023
• Device Model Number: G31138
• Device Catalogue Number: KSAW-6.0-38-90-RB-SHTL-FLEX-HC
• Device Lot Number: 13315288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 11/09/2020; 03/31/2021
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 11/17/2020; 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other