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	02/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The reported device is not available for evaluation.Investigation- a review of the complaint history, device history record, specifications, ifu, quality control and visual inspection of the returned device was conducted.We did not identify events related to the reported issue during a review of related manufacturing or quality records.Review of the associated device history record did not identify non-conformances that may be related to this reported incident.No similar complaints have been reported for this lot number.A definitive root cause could not be determined, but the device failure could have possibly been caused by patient anatomy or because of too much force applied on the device or due to manufacturing defect.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.
Event or Problem Description
It was reported that during a vascular angiogram procedure using a flexor shuttle tibial guiding sheath, when the user began to remove the catheter resistance was met.The external portion of the catheter and some of the internal portion were removed from the patient however, fluoroscopy showed that a portion of the catheter remained in the artery.The patient was taken to surgery and a cut down procedure was performed to remove the remaining portion of the product.Statement from email: patient had successful removal of severed catheter components.Was transferred in stable condition to a tertiary care center.

• 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: 6411035
• Report Number: 1820334-2017-00358
• Device Sequence Number: 16373345
• Product Code: DYB
• UDI-Device Identifier: 00827002481947
• UDI-Public: (01)00827002481947(17)180903(10)6177596
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: KSAW-5.0-18/38-110-RB-SHTL-HC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2017
• Initial Report FDA Received Date: 03/16/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 68