MAUDE Adverse Event Report: GREATBATCH MEDICAL KIT, PTFE, INTRODUCER 1-PACK, 8FR; INTRODUCER, CATHETER

Model Number	667091-303
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: during a pacemaker implant, the doctor opened an 8f introducer and saw that the sheath was broken from the factory.The introducer was not used.This is the same event as mdr 2183787-2017-00122.
Additional Manufacturer Narrative
Investigation revealed that product problem is an isolated occurrence.No corrective actions necessary.

• Brand Name: KIT, PTFE, INTRODUCER 1-PACK, 8FR
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane; minneapolis MN 55441
• MDR Report Key: 7045058
• Report Number: 2183787-2017-00123
• Device Sequence Number: 1852082
• Product Code: DYB
• UDI-Device Identifier: 00802526527845
• UDI-Public: 00802526527845
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/02/2019
• Device Model Number: 667091-303
• Device Lot Number: W3732095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/25/2017
• Supplement Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 01/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR