MAUDE Adverse Event Report: MEDTRONIC MEXICO CATHERA; CATHETER, CONTINUOUS FLUSH

Model Number	FG19120-1030-1S
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/29/2024
Type of Reportable Event	Serious Injury
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 a report that  the patient was being treated for vasospasm in the right anterior cerebral artery (aca).The phenom plus was parked in the right internal carotid artery (ica).A scepter balloon was placed through the phenom plus and parked in the aca.The physician removed the phenom plus and the scepter from the patient.When the physican attempted to advance the phenom plus back up into the ica the physician noticed that he could not see the tip of the phenom plus.The plus was removed and noted that the tip was gone.The tip floated out into the right m4 segment of the middle cerebral artery (mca).The marker band dislodged.The catheter tip was not shaped.The marker band remains in the patient's m4.There was surgical or medicinal intervention required.They attempted to retrieve the tip with aspiration catheter (red 43) and a microcatheter (sl10) but were unsuccessful.The device and any accessories were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment right middle cerebral artery (mca) vasospasm.It was noted the patient's vessel tortuosity was moderate.The access vessel was right radial with a diameter of 3mm.Ancillary devices include a synchro select (b)(6), asahi chikai (b)(6) guidewire, scepter xc (b)(6).
Event or Problem Description
It was clarified that "there was surgical or medicinal intervention required" during the same procedure.Patient is in bad shape due to a massive aneurysm rupture several days prior.The cause of the issue was not determined.
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.
Additional Manufacturer Narrative
Product analysis # (b)(4):¿ equipment used: vis (m-81805), 203cm ruler (m-83360) ¿ as found condition: the phenom plus catheter was returned for analysis within a shipping box and a plastic bio-pouch.¿ damage location details: no damages were found with the phenom plus catheter hub.No bends or kinks were found with the phenom plus catheter body.The phenom plus catheter distal marker was found dislodged from the catheter.The tubing material at the distal marker separation exhibited plastic deformation (jagged edges).¿ testing/analysis: none ¿ conclusion: based on the device analysis and reported information, the customer¿s ¿marker band dislodged¿ report was confirmed as the phenom plus catheter distal marker was found dislodged from the catheter.Possible causes of ¿marker band dislodged¿ include advancing/retrieving the catheter against resistance, vessel tortuosity, kink/damage in guide catheter/sheath, balloon guide catheter, hard clots/calcifications in the navigation tract which may snag the catheter, or catheter tip shaping.However, the case of the catheter damage could not be determined.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: CATHERA
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 19042182
• Report Number: 9612164-2024-01604
• Device Sequence Number: 8483018
• Product Code: KRA
• UDI-Device Identifier: 00763000399733
• UDI-Public: 00763000399733
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/12/2026
• Device Model Number: FG19120-1030-1S
• Device Catalogue Number: FG19120-1030-1S
• Device Lot Number: 227300507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2024
• Supplement Date Received by Manufacturer: 04/05/2024; 05/03/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 04/30/2024; 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 75 KG