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 Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the hub broke into 3 pieces into the incision site.The physician picked out pieces and closed the incision.

• 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: 6129168
• Report Number: 2183787-2016-00100
• Device Sequence Number: 13491096
• Product Code: DYB
• UDI-Device Identifier: 00821329600579
• UDI-Public: (01)00821329600579(11)150730(17)170730(10)W3058709
• Combination Product (Y/N): N
• 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): 10/28/2016

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: 07/30/2017
• Device Model Number: 1000093-015
• Device Catalogue Number: 7440 (BSC)
• Device Lot Number: W3058709
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2016
• Initial Report FDA Received Date: 11/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1