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	09/28/2016
Type of Reportable Event	Malfunction
Event or Problem Description
As reported the arm of the peel away sheath broke off and the sheath needed to be cut.The sheath was being cut chunks of the sheath were falling off into the wound.Sheath was removed from patient's chest successfully.

• 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: 6144534
• Report Number: 2183787-2016-00102
• Device Sequence Number: 710001
• Product Code: DYB
• UDI-Device Identifier: 10821329600576
• UDI-Public: (01)10821329600576(17)180628(10)W3479566
• 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): 11/03/2016

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: 06/28/2018
• Device Model Number: 1000093-001
• Device Lot Number: W3479566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2016
• Initial Report FDA Received Date: 12/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1