MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) VISUALIZATION STYLET 1 MM DIAMETER; INSTRUMENT, SURGICAL, NON-POWERED

Catalog Number 020-2301

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2016

Event Type  malfunction  

Manufacturer Narrative

Product is class i for us regulations and does not require a 510(k) designation.No parts have been received by the manufacturer for evaluation.A capa was opened to investigate this concern.

Event Description

A site representative reported that during setup for a laser induced thermal therapy (litt) the visualization stylet appeared to move when brought into the mr magnetic field.They opened a new accessory kit and continued with the procedure.This issue was identified prior to being used on the patient with no clinical impact.

Manufacturer Narrative

The capa investigation found that the root cause for this issue as follows: although a cross-functional team could not reach a definitive root cause due to lack of information from a former supplier, the team determined that the probable root cause was that the former supplier pulled the incorrect material or product, due to similarities of the products involved (including identical hubs and similar looking wires-titanium vs.Stainless steel).A hazard analysis found that the patient safety risk was determined to be medium.The compliance risk was determined to be high as the product was misbranded.Although the part was not returned and the event was unable to be confirmed in this complaint, a review of the complaint history found one other complaint (reported under mdr 1723170-2016-00999) in which the part was returned and the reported issue was confirmed.As a result of the capa investigation, both suspect lots were put on product hold order and all on hand inventory in the medtronic distribution center was returned to the manufacturer for analysis.The returned inventory was screened for non-conforming stylets by exposing them to a static 1.5t magnetic field of a ge signa mri scanner.None of the returned stylets reacted to the magnetic field.These lots were then returned to inventory.This indicates that a portion of the lot may have been non-conforming but not the entire lot.A review of the former supplier manufacturing process found that the former supplier specified the stiffening stylet wire to be stainless steel.However, this allows the stylet wire supplier to substitute different stainless steel alloys.In november 2014, medtronic changed the specification to specify the stainless steel alloy, (b)(4).The suspect lot was manufactured in june of 2015.Although no evidence was found, it is possible that stylet wire purchased before november 2014 and remaining in stock could have been used to build the suspect lot.Both stylets are similar in appearance to each other.The titanium stylet wire is slightly less rigid and has a matte appearance when compared to the stainless steel wire.These are very minor differences that would likely go unnoticed.The former supplier is no longer an approved medtronic supplier for production use, and a new supplier is being qualified to supply these products.

• Brand Name: VISUALIZATION STYLET 1 MM DIAMETER
• Type of Device: INSTRUMENT, SURGICAL, NON-POWERED
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: amos jarrette ; 826 coal creek circle; louisville, CO 80027 ; 7208902082
• MDR Report Key: 5744721
• MDR Text Key: 48025428
• Report Number: 1723170-2016-01212
• Device Sequence Number: 1
• Product Code: HAO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/13/2017
• Device Catalogue Number: 020-2301
• Device Lot Number: 151481
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2015
• 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 Age: 65 YR
• Patient Weight: 103