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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.
Event or Problem Description
Blood leakage from the tuohy-borst was confirmed during use.Then, another device was used instead to finish the procedure.There have been no adverse effects to the patient reported.There have been no adverse effects to the patient reported.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, device history record, documentation, specifications, and quality control was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported blood leak complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
Blood leakage from the tuohy-borst was confirmed during use.Then, another device was used instead to finish the procedure.There have been no adverse effects to the patient reported.There have been no adverse effects to the patient reported.

• Brand Name: FLEXOR ANSEL GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5575973
• Report Number: 1820334-2016-00222
• Device Sequence Number: 10868816
• Product Code: DYB
• UDI-Device Identifier: 00827002299962
• UDI-Public: (01)00827002299962(17)181130(10)6412719
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2016

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-6.0-18/38-55-RB-ANL1-HC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/18/2016
• Device Age: 5 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2016
• Supplement Report FDA Received Date: 11/17/2016
• 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