MAUDE Adverse Event Report: COOK INC FLEXOR HIGH-FLEX ANSEL 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	03/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The product was returned for evaluation.A review of the complaint history, device history record, ifu and quality control of the reported device was conducted.No events related to the reported issue were found 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.Also, the ifu states that the dilator should be inserted prior to removal of the sheath.It was reported that the dilator had only been inserted once resistance was encountered.It is possible that not inserting the dilator before attempting to remove the sheath could have contributed to this occurrence as well.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 an arteriogram using a flexor high-flex ansel guiding sheath, the user was coming back through a calcified bifurcation and felt resistance without the dilator.The dilator was put in place as the user continued to remove the device and the sheath fractured off into the patient.A cut down procedure was required to remove the remaining portion of the device from the patient.There were no adverse effects reported that the patient experienced as a result of this event.

• Brand Name: FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6490387
• Report Number: 1820334-2017-00614
• Device Sequence Number: 849461
• Product Code: DYB
• UDI-Device Identifier: 00827002562202
• UDI-Public: (01)00827002562202(17)190617(10)7052030
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2017

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: KCFW-5.0-35-70-RB-HFANL0-HC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2017
• Initial Report FDA Received Date: 04/13/2017
• 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