MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC PASSIVE BIOPSY NEEDLE KIT; INSTRUMENT, STEREOTAXIC

Model Number 9733068

Device Problem Material Integrity Problem (2978)

Patient Problems Tissue Damage (2104); Iatrogenic Source (2498)

Event Date 02/19/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received information regarding a navigation system being used in a cranial biopsy.It was reported that there was an issue with the passive biopsy needle.The needle could not be removed from the stylet.It was determined the two fins of the needle were aligned with two dents in the stylet tubing, which prevented removal.The surgeon used the track that was already provided from insertion of the biopsy needle and used another tool to perform the biopsy.Due to the reported issue, the procedure was continued without navigation.The issue did not result in a procedure delay.There was no reported impact on patient outcome.

Manufacturer Narrative

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

Event Description

Additional information was received stating this was user error as the health care professional had tightened the locking screw way too tight causing it to be dented in.

• Brand Name: PASSIVE BIOPSY NEEDLE KIT
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9792911
• MDR Text Key: 182163951
• Report Number: 1723170-2020-00758
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K971247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2020
• Device Model Number: 9733068
• Device Catalogue Number: 9733068
• Device Lot Number: 066520118A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2020
• Date Device Manufactured: 07/20/2018
• 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
• Patient Age: 39 YR