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

Model Number	1000093-004
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: blood egress when dilator removed after insertion.
Event or Problem Description
Updated information received from the customer on 13-dec-2018 confirmed that this event was a duplicate of mdr 2183787-2018-00079 (b)(4).

• Brand Name: OPTISEAL VALVED PTFE PEELABLE INTRODUCER 9F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): GREATBATCH MEDICAL; 2360 berkshire lane; plymouth MN 55441
• MDR Report Key: 8129363
• Report Number: 2183787-2018-00097
• Device Sequence Number: 1770328
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/09/2020
• Device Model Number: 1000093-004
• Device Lot Number: W4392170
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1