MAUDE Adverse Event Report: FUJI SYSTEMS CORPORATION CELLO BALLOON GUIDE CATHETER; CATHETER, PERCUTANEOUS

Model Number	1610590
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that a cello balloon guide catheter encountered an issue where the balloon tore off.It was thought to have been due to calcification of the veins.The reported device and accessory devices were prepared as indicated in the instruction for use (ifu).The catheter was flushed as indicated in the ifu.There were no patient symptoms or complications associated with this event.
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: CELLO BALLOON GUIDE CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): FUJI SYSTEMS CORPORATION; 200-2 aza ohira, odakura; nishigo, nishi shirakawa gun; fukushima-ken 961-8 061; JA 961-8061
• Manufacturer (Section G): FUJI SYSTEMS CORPORATION; 200-2 aza ohira, odakura; nishigo, nishi shirakawa gun; fukushima-ken 961-8 061; JA 961-8061
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 19809141
• Report Number: 3000308637-2024-00002
• Device Sequence Number: 12700133
• Product Code: DQY
• UDI-Device Identifier: 14544050120743
• UDI-Public: 14544050120743
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K120781
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2024

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 Expiration Date: 10/01/2026
• Device Model Number: 1610590
• Device Catalogue Number: 1610590
• Device Lot Number: 5300398
• 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: 07/19/2024
• Initial Report FDA Received Date: 07/23/2024
• Date Device Manufactured: 10/01/2023
• 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