MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORP. PRECISION EPIMED COUDE NEEDLE

Model Number SC-4210

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/19/2017

Event Type  malfunction  

Event Description

Patient was undergoing a procedure with a dorsal column stimulator and with the manipulation of the boston scientific epidural needle, the plastic attachment broke off the metal part of the needle x2.All parts were retrieved from the patient and set back together to check for missing pieces.The case was done under fluoroscopy and no pieces were visualized.

• Brand Name: PRECISION EPIMED COUDE NEEDLE
• Type of Device: COUDE NEEDLE
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORP.; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 6756430
• MDR Text Key: 81591803
• Report Number: MW5071298
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: SC-4210
• Device Catalogue Number: M365SC42100
• Device Lot Number: 12147805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR