MAUDE Adverse Event Report: GREATBATCH MEDICAL BULK FLOWGUARD 16FR; INTRODUCER, CATHETER

Model Number 10614-011

Device Problem Device Issue (2379)

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

Event Date 02/09/2017

Event Type  malfunction  

Manufacturer Narrative

Visual inspection of the returned sheath observed both handles detached from the tube.Tube hole punch marks were visible below the handle.After molding the sheaths are 100% visually inspected to verify the hole punches are not visible below the handle.During manufacturing, sheaths are monitored and random samples are visually inspected for defects, dimensionally inspected for length, and destructively tested for handle integrity.During packaging, sheaths are 100% visually inspected for defects, including the presence of hole punches that are visible below the handle.While there are several contributing root causes, the likely cause of the handles detaching is due to improper tube placement during molding.The occurrence rate is within the acceptable occurrence rate per greatbatch medical risk documentation.Corrective and preventive actions are detailed in a capa e.G.Procedural improvements to the inspection process.

Event Description

As reported: the customer had an issue with a dialysis catheter.The customer states the interventionalist (ir) was placing a palindrome dialysis catheter that resulted in the ir having to retrieve the pull-apart sheath out of the right internal jugular.When the doctor broke the sides of the pull-apart sheath and started peeling it away, it fell and was not retrievable.The ir doctor had to snare it out through the groin.Reference covidien's report: 3009211636-2017-05019.

• Brand Name: BULK FLOWGUARD 16FR
• 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: 6505036
• MDR Text Key: 73251137
• Report Number: 2183787-2017-00049
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040150
• 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: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10614-011
• Device Lot Number: W3192239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2015
• 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 Outcome(s): Required Intervention