MAUDE Adverse Event Report: GREATBATCH MEDICAL PTFE PEELABLE INTRODUCER

Model Number	1000558-012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/12/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during the first part of the crt-d implant procedure the physician was trying to find the subclavian vein with a needle from model # 7096 (peelable introducer kit).After some attempts the patient started to cough and some blood was seen coming from the patient's mouth.The procedure was interrupted and the patient was brought to another department of the hospital for further analysis.

• Brand Name: PTFE PEELABLE INTRODUCER
• Common Device Name: PTFE PEELABLE INTRODUCER
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane; minneapolis MN 55441
• MDR Report Key: 5886027
• Report Number: 2183787-2016-00067
• Device Sequence Number: 774734
• Product Code: DYB
• UDI-Device Identifier: 00802526527876
• UDI-Public: (01)00802526527876(17)170914(10)W3220632
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102540
• 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): 07/20/2016

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: 09/14/2017
• Device Model Number: 1000558-012
• Device Catalogue Number: BSC 7096
• Device Lot Number: W3220632
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2016
• Initial Report FDA Received Date: 08/18/2016
• 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