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

Model Number	1000558-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that when puncturing during implant a pneumothorax occurred.The doctor assumes the pneumothorax was caused by the puncture with the guiding catheter.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: 5398728
• Report Number: 2183787-2016-00005
• Device Sequence Number: 19098090
• Product Code: DYB
• UDI-Device Identifier: 00802526527807
• UDI-Public: (01)00802526527807(17)170824(10)W3183154
• 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: Nurse
• Report Date (Section B): 01/08/2016

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: 08/24/2017
• Device Model Number: 1000558-001
• Device Catalogue Number: BSC7087
• Device Lot Number: W3183154
• 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