MAUDE Adverse Event Report: GREATBATCH MEDICAL OPTISEAL VALVED PTFE PEELABLE INTRODUCER 9F; INTRODUCER, CATHETER

Model Number	1003975-004
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when they took the dilator out of the sheath, the valve leaked blood through it.The valve was not preventing bleedback, but rather just allowing blood to come through the valve.The physician said he had to hurry and put the lead down quicker since it was leaking.There was no reported impact on the patient.The was just a nuisance for the physician.

• Brand Name: OPTISEAL VALVED PTFE PEELABLE INTRODUCER 9F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane; minneapolis MN 55441
• MDR Report Key: 8248877
• Report Number: 2183787-2019-00007
• Device Sequence Number: 16691843
• Product Code: DYB
• UDI-Device Identifier: 00821329601385
• UDI-Public: 00821329601385
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K130559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2018

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: 08/15/2020
• Device Model Number: 1003975-004
• Device Catalogue Number: 1003975-004
• Device Lot Number: W4440792
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1