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

Model Number	1000093-001
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A broken and peeled sheath was returned for analysis.The returned sheath was visually inspected and confirmed the wing on the non-sideport handle detached.Visual inspection observed markings on the handle indicating the user used other means to break and peel the handle.The support peg on the handle that holds the valve was broken off of the handle.The valve and the cap on the broken handle were also detached.A small fragment of sheath handle was also observed inside the detached valve piece.Based on event description, the fragments likely detached when the handle was split by other means.Review and confirmation of manufacturing records was performed.No discrepancies were noted.All records indicate the device met specification prior to leaving greatbatch medical.Greatbatch is unable to determine the cause of this incident at this time.Due to the nature of this event and similar occurrences, further investigation is required to determine root cause.An updated report with details of the investigation will be submitted to the fda as information becomes available.
Event or Problem Description
It was reported that when trying to split the sheath the left-hand wing broke off at the juncture with the valve.A kelly clamp was used to split the sheath.There were tiny residual pieces of plastic that landed on the incision site.The pieces were removed and there was no patient consequence.

• 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: 5967014
• Report Number: 2183787-2016-00081
• Device Sequence Number: 18985481
• Product Code: DYB
• UDI-Device Identifier: 10821329600576
• UDI-Public: (01)10821329600576(17)171027(10)W3264750
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/22/2016

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: 10/27/2017
• Device Model Number: 1000093-001
• Device Lot Number: W3264750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2016
• Initial Report FDA Received Date: 09/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention