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

Model Number	1000093-004
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2017
Type of Reportable Event	Malfunction
Event or Problem Description
As reported md found piece of valve from the sheath in the pocket prior putting device in pocket.The md never saw the piece fall into pocket during the peel away process.
Additional Manufacturer Narrative
Review of the manufacturing records did not reveal any discrepancies that would have contributed to this event.The investigation revealed that the failure mode could not be recreated and that the cause is possibly due to operational context.This is the first occurrence in at least the last 3 years for this failure mode, and the event is an isolated occurrence.No corrective actions necessary.

• 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: 7022424
• Report Number: 2183787-2017-00121
• Device Sequence Number: 1548640
• Product Code: DYB
• UDI-Device Identifier: 00821329600227
• UDI-Public: 00821329600227
• 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,Followup,Followup
• Report Date (Section B): 10/16/2017

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: 05/17/2019
• Device Model Number: 1000093-004
• Device Lot Number: W3759975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/16/2017
• Supplement Date Received by Manufacturer: 10/16/2017; 10/16/2017
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 03/07/2018; 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 91