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

Model Number 667091-303

Device Problem Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/20/2017

Event Type  malfunction  

Event 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 2183787-2017-00123.

• Brand Name: KIT, PTFE, INTRODUCER 1-PACK, 8FR
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane; minneapolis MN 55441
• Manufacturer Contact: rhonda stager ; 2300 berkshire lane; minneapolis, MN 55441 ; 7639518376
• MDR Report Key: 7045060
• MDR Text Key: 93181709
• Report Number: 2183787-2017-00122
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00802526527845
• UDI-Public: 00802526527845
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102540
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2019
• Device Model Number: 667091-303
• Device Lot Number: W3732095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2017
• Initial Date FDA Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 42 YR