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

Model Number G13264

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 01/28/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter: occupation, lab manager.Device evaluated by mfg, device evaluation has begun; however, a conclusion is not yet available.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during a neurological intervention, the tip of a flexor shuttle tibial guiding sheath sheared/separated in the patient.The separated portion was retrieved and nothing remains in the patient.It is unknown at this time how the separated portion of the sheath was retrieved or how the procedure was completed.Upon return and initial evaluation of the device, the separated sheath material was connected by elongated coil.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information has been requested.

Event Description

Additional information was received 08feb2021.Access was obtained in the jugular vein to target the sigmoid sinus.The anatomy was tortuous but not particularly difficult.Heparin was given throughout the case and latex gloves were worn.Vessel spasms were not noted.The sheath had been in place for up to two hours prior to separating upon removal.Resistance was reported upon removal of the device.A wire guide and a stent were in the lumen of the device upon removal, and the user thought that the resistance was due to stiffness of the wire and friction caused by the stent; however, resistance was suddenly lost, and the sheath fractured.The dilator was not in place at the time of separation; however, it was reportedly reinserted to assist with removal.The entire system was removed, with the wire in place, as the sheath was wrapped around the wire and did not fully separate.No portion of the sheath remained in the patient.The procedure was aborted and rescheduled for a direct jugular stick.Reportedly, the patient has experienced worsening of vision loss in the left eye.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: b5, d11 d11: concomitant products= amplatz wire, cook zilver stent, 0.035 terumo glidewire, marksman microcatheter, synchro 2 microwire.Summary of event: as reported, during a neurological intervention, the tip of a flexor shuttle tibial guiding sheath sheared/separated in the patient.The separated portion was retrieved, and nothing remains in the patient.It is unknown at this time how the separated portion of the sheath was retrieved or how the procedure was completed.Upon return and initial evaluation of the device, the separated sheath material was connected by elongated coil.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information was received 08feb2021.Access was obtained in the jugular vein to target the sigmoid sinus.The anatomy was tortuous but not particularly difficult.Heparin was given throughout the case and latex gloves were worn.Vessel spasms were not noted.The sheath had been in place for up to two hours prior to separating upon removal.Resistance was reported upon removal of the device.A wire guide and a stent were in the lumen of the device upon removal, and the user thought that the resistance was due to stiffness of the wire and friction caused by the stent; however, resistance was suddenly lost, and the sheath fractured.The dilator was not in place at the time of separation; however, it was reportedly reinserted to assist with removal.The entire system was removed, with the wire in place, as the sheath was wrapped around the wire and did not fully separate.No portion of the sheath remained in the patient.The procedure was aborted and rescheduled for a direct jugular stick.Reportedly, the patient has experienced worsening of vision loss in the left eye.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.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.The sheath was separated in two sections but was attached by elongated coil.The dilator remained lodged in the sheath.The separated material section measured 6.2cm.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.Evidence from the complaint file, device history record, complaint history, manufacturing documents, and device failure analysis suggests 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 product ifu instructs the user to inspect the product to ensure no damage has occurred upon removal from the package and to reinsert the dilator if resistance is felt during removal.The ifu states that the device is intended ¿to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.¿ 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 the patient¿s condition and unintended use error contributed to this event.The device was used for a neurovascular procedure.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
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11292429
• MDR Text Key: 230693242
• Report Number: 1820334-2021-00269
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002132641
• UDI-Public: (01)00827002132641(17)230728(10)13332074
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2023
• Device Model Number: G13264
• Device Catalogue Number: KSAW-6.0-38-90-RB-SHTL-HC
• Device Lot Number: 13332074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention