MAUDE Adverse Event Report: MEDTRONIC DOMINICANA CATHETER PASSER; CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TER

Model Number	48409
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/26/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Medtronic received information regarding a catheter passer.It was reported that the tip of catheter passer, used for right ventricu loperitoneal shunt insertion with laparoscopic assist, broke off during tunnelling.  surgeon was unable to to locate or retrieve in patient.The tip was not radiopaque so x-ray imaging was not helpful in retrieval. surgeon decided to leave missing piece in-situ.

• Brand Name: CATHETER PASSER
• Common Device Name: CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TER
• Manufacturer (Section D): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer (Section G): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer Contact: justin ellis ; 4620 n. beach st.; fort worth, TX 76137 ; 7635265677
• MDR Report Key: 23777099
• Report Number: 9612501-2025-03295
• Device Sequence Number: 10091359
• Product Code: MAJ
• UDI-Device Identifier: 00763000027841
• UDI-Public: (01)00763000027841(17)300406(10)0231248901
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K911382
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2025

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: 48409
• Device Catalogue Number: 48409
• Device Lot Number: 0231248901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 12/11/2025
• Date Device Manufactured: 05/02/2025
• 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