MAUDE Adverse Event Report: GREATBATCH MEDICAL OPTISEAL VALVED PTFE PEELABLE INTRODUCER 7F; INTRODUCER, CATHETER

Model Number	1000093-002
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sheath did not break appropriately.The hard clear plastic piece had broken apart from the top rear portion of the light blue handle (not the clear tubing, but the other small clear piece where lead enters).The lead had been attached to this hard clear plastic area when it broke.The blue handle remained in one piece; it did not break in half.

• Brand Name: OPTISEAL VALVED PTFE PEELABLE INTRODUCER 7F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane; minneapolis MN 55441
• MDR Report Key: 7133057
• Report Number: 2183787-2017-00133
• Device Sequence Number: 19112158
• Product Code: DYB
• UDI-Device Identifier: 00821329600203
• UDI-Public: 00821329600203
• 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): 11/27/2017

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: 08/24/2017
• Device Model Number: 1000093-002
• Device Lot Number: W3901690
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 12/20/2017
• 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