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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
A flexor shuttle tibial guiding sheath was used in a carotid intervention in the right groin via contralateral approach.It was reported that during removal of the sheath, the tip broke inside of the patient.A dilator was not inserted into the sheath prior to removal.The patient was taken to the operating room to remove the tip of the device.The tip was removed successfully.According to the initial reporter, the patient did not experience any other adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.A flexor shuttle tibial guiding sheath was returned for investigation.The sheath tubing was separated at the distal end and exposed coil was exiting the separation site.The exposed coil is 2.3cm in length.Accordion damage is noted a 61.5cm from the proximal hub and is 10.6cm in length.The distal separated section of tubing was not returned.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.A dilator was not inserted into the sheath prior to removal.Per the ifu, ¿withdraw the sheath and dilator as a unit.¿ ¿before withdrawing the sheath through tortuous anatomy, insert the introducer dilator to avoid possible breakage.¿ based on the information provided, examination of the returned product, and the results of our investigation; the root cause has been determined to be related to user technique during removal of the sheath from the body.The ifu, instructs the user to remove the sheath and dilator as a unit as dilators are stiff, thick-walled catheters, with a long tapered end they provide support to the flexible sheath during removal.The appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: FLEXOR SHUTTLE TIBIAL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6886013
• Report Number: 1820334-2017-03204
• Device Sequence Number: 13655398
• Product Code: DYB
• UDI-Device Identifier: 00827002132641
• UDI-Public: (01)00827002132641(17)191006(10)7337493
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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): 11/30/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: KSAW-6.0-38-90-RB-SHTL-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/20/2017
• Supplement Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 09/22/2017
• Supplement Report FDA Received Date: 11/30/2017
• 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: Required Intervention
• Patient Age: 67 YR