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 Consequences Or Impact To Patient (2199)
Date of Event	04/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.(b)(6) attempted to split the 6 fr sheath the wing broke off.Physician had to use an instrument to hold and break sheath.No patient complications have been reported as a result of this event.

• 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: 8630166
• Report Number: 2183787-2019-00044
• Device Sequence Number: 1924641
• Product Code: DYB
• UDI-Device Identifier: 10821329600576
• UDI-Public: 10821329600576
• 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): 05/21/2019

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: 01/21/2019
• Device Model Number: 1000093-001
• Device Lot Number: W4679494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 05/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1