MAUDE Adverse Event Report: ADVANCED URO-SOLUTIONS, L.L.C. NEXDRIVE; INSTRUMENT, STEREOTAXIC

Model Number MI-1000

Device Problems Fitting Problem (2183); Insufficient Information (3190)

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

Event Date 07/10/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported during the procedure the tube collet on the nexdrive was very tight while inserting the alpha omega micro cannula.No environmental/external/patient factors were thought to have led or contributed to the issue.The physician was able to insert the tube correctly but noted a very tight fit much more than usual.No troubleshooting was done and the issue was resolved at the time of the report.The patient was alive without injury at the time of the report.No complications were reported or anticipated.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis of the nexdrive revealed the returned device passed all testing in the laboratory and no anomalies were identified.(b)(4) no longer apply.(b)(4) now apply.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: NEXDRIVE
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): ADVANCED URO-SOLUTIONS, L.L.C.; 7842 hickory flat highway; suite d; woodstock GA 30188
• MDR Report Key: 7686941
• MDR Text Key: 114455528
• Report Number: 3012165443-2018-00008
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994747853
• UDI-Public: 00613994747853
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2018
• Device Model Number: MI-1000
• Device Catalogue Number: MI-1000
• Device Lot Number: 082629617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Date Manufacturer Received: 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 82