MAUDE Adverse Event Report: GREATBATCH MEDICAL PTFE PEELABLE INTRODUCER KIT, 6FR; INTRODUCER, CATHETER

Model Number	1000558-001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	04/06/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient suffered a pneumothorax following pacemaker insertion.The patient was stable and doing well the following morning.No further information was provided in regards to discharge from the hospital.Patient information is unavailable.

• Brand Name: PTFE PEELABLE INTRODUCER KIT, 6FR
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane n; minneapolis MN 55441
• MDR Report Key: 5673054
• Report Number: 2183787-2016-00048
• Device Sequence Number: 26840
• Product Code: DYB
• UDI-Device Identifier: 00802526527807
• UDI-Public: (01)00802526527807(17)171015(10)W3252050
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2016

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: 10/15/2017
• Device Model Number: 1000558-001
• Device Catalogue Number: BSC7087
• Device Lot Number: W3252050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2016
• Initial Report FDA Received Date: 05/23/2016
• 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