MAUDE Adverse Event Report: GREATBATCH MEDICAL OPTISEAL VALVED PTFE PEELABLE INTRODUCER 11F; INTRODUCER, CATHETER

Model Number	1000093-006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	06/27/2017
Type of Reportable Event	Malfunction
Event or Problem Description
As reported the physician was performing a cephalic cut down on an extremely obese patient.The cephalic vein appeared large and more blood than usual pooled and spurted out during the procedure.The physician stated that the patient had high venous pressure along with the introducer doing a poor job of preventing back bleeding through the valve.

• Brand Name: OPTISEAL VALVED PTFE PEELABLE INTRODUCER 11F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane; minneapolis MN 55441
• MDR Report Key: 6755325
• Report Number: 2183787-2017-00092
• Device Sequence Number: 150097
• Product Code: DYB
• UDI-Device Identifier: 00821329600586
• UDI-Public: (01)00821329600586(17)171006(10)W3241210
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K093232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 07/03/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/06/2017
• Device Model Number: 1000093-006
• Device Catalogue Number: 1000093-006
• Device Lot Number: W3241210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2017
• Initial Report FDA Received Date: 07/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR