MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA STYLET KIT; STYLET, CATHETER

Model Number	6057-45
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to use the stylets sterile barrier was breached.It was noted that a container with a bag of ice was inad vertently left near stylets and ice seeped into the stylet packaging.It was noted that water insulation was found in stylet packaging.The stylets were attempted/not used. there was no patient involvement.
Additional Manufacturer Narrative
Continuation of d10: product id 6057-58 (va2t192); product type: 0284-stylet; implant date n/a; explant date n/a product id 6057-58 (va3116x); product type: 0284-stylet; implant date n/a; explant date n/a product id 6057-52 (va31b0m); product type: 0284-stylet; implant date n/a; explant date n/a product id 6057-52 (va2j93d); product type: 0284-stylet; implant date n/a; explant date n/a product id 6057-52 (va31gww); product type: 0284-stylet; implant date n/a; explant date n/a product id 6057-65 (va32123); product type: 0284-stylet; implant date n/a; explant date n/a product id 6057-65 (va2lhqc); product type: 0284-stylet; implant date n/a; explant date n/a product id 6082-45 (va2t5td); product type: 0284-stylet; implant date n/a; explant date n/a product id 6082-52 (va2tq0y); product type: 0284-stylet; implant date n/a; explant date n/a medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: STYLET KIT
• Common Device Name: STYLET, CATHETER
• Manufacturer (Section D): MEDTRONIC PUERTO RICO VILLALBA; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MEDTRONIC PUERTO RICO VILLALBA; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 23400785
• Report Number: 2649622-2025-30125
• Device Sequence Number: 15961120
• Product Code: DRB
• UDI-Device Identifier: 00763000058968
• UDI-Public: (01)00763000058968(17)280131(10)VA2WU95
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: PRE-AMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6057-45
• Device Catalogue Number: 6057-45
• Device Lot Number: VA2WU95
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/15/2025
• Date Device Manufactured: 02/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown