MAUDE Adverse Event Report: GREATBATCH MEDICAL OPTISEAL VALVED PTFE PEELABLE INTRODUCER 6F; INTRODUCER, CATHETER

Model Number	1000093-015
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2017
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: when the physician was breaking away the sheath - both tabs broke off, and the hub broke into several pieces.The physician had to use some clamps to tear it away.No issue for patient.This event is related to mdr 2183787-2017-00086.

• Brand Name: OPTISEAL VALVED PTFE PEELABLE INTRODUCER 6F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane; minneapolis MN 55441
• MDR Report Key: 6731737
• Report Number: 2183787-2017-00087
• Device Sequence Number: 19013884
• Product Code: DYB
• UDI-Device Identifier: 00821329600579
• UDI-Public: (01)00821329600579(11)171020(17)190307(10)W3645161
• 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): 07/12/2017

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: 03/07/2019
• Device Model Number: 1000093-015
• Device Lot Number: W3645161
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 07/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1