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	06/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device analysis did not detect any evidence of a manufacturing, material or design issue.The rate of occurrence is within predicted levels in the risk management document.There were no allegations or evidence of particulates or potential for particulates.This report is being submitted since the device involved shares the same product family, but with design differences, as other devices that were mdr reported.
Event or Problem Description
As reported when the physician went to split the introducer, one of the orange tabs broke off.Introducer removed using surgical instruments.

• 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: 6962609
• Report Number: 2183787-2017-00117
• Device Sequence Number: 718559
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2017

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: 04/12/2019
• Device Model Number: 1000093-002
• Device Lot Number: W3716651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR