MAUDE Adverse Event Report: GREATBATCH MEDICAL OPTISEAL VALVED PTFE PEELABLE INTRODUCER SP KIT, 5 PACK, 6FR, 13CM; INTRODUCER, CATHETER

Model Number	1000093-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Laceration(s) (1946)
Date of Event	05/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Good morning, i had a significant issue with an optiseal 6f sheath this morning during a pacemaker implant.The implanting physician was injured/cut during usage of the sheath.I am not sure what to do from here.Would someone please give me a call to discuss further.

• Brand Name: OPTISEAL VALVED PTFE PEELABLE INTRODUCER SP KIT, 5 PACK, 6FR, 13CM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane north; minneapolis MN 55441
• Manufacturer Contact: samuel master ; 2300 berkshire lane; minneapolis, MN 55441 ; 7639518115
• MDR Report Key: 14437727
• Report Number: 2183787-2022-00034
• Device Sequence Number: 17537658
• Product Code: DYB
• UDI-Device Identifier: 00821329600579
• UDI-Public: (01)00821329600579(11)210525(17)230525(10)W6418582
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K063182
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2022

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: 05/25/2023
• Device Model Number: 1000093-001
• Device Lot Number: W6418582
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown