MAUDE Adverse Event Report: GREATBATCH MEDICAL OPTISEAL VALVED PTFE PEELABLE INTRODUCER 7 FR, 25 CM; INTRODUCER, CATHETER

Model Number	1000093-009
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	12/30/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 5076-52 was implanted, right before 5076-45 was implanted, it was found that the optiseal sheath had perforated the svc when contrast was shot through it.Patient was then taken to the operating room for open chest surgery to repair the svc.Surgeon explanted the ventricular lead.

• Brand Name: OPTISEAL VALVED PTFE PEELABLE INTRODUCER 7 FR, 25 CM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane n; minneapolis MN 55441
• MDR Report Key: 5399680
• Report Number: 2183787-2016-00006
• Device Sequence Number: 996894
• Product Code: DYB
• UDI-Device Identifier: 10821329600248
• UDI-Public: (01)10821329600248(17)161222(10)W2973242
• 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: Medical Equipment Company Technician/Representative
• Report Date (Section B): 01/20/2016

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: 12/22/2016
• Device Model Number: 1000093-009
• Device Lot Number: W2973242
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2016
• 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
• Patient Age: 87 YR