MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ION; CATHETER

Model Number	490105-11
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an ion endoluminal lung biopsy procedure the catheter would not relax and the patient experienced hemorrhaging.The physician was at the end of the ion procedure and while trying to retract the catheter it would not relax.A fluoroscopy was performed, and it was noted that the catheter was hooked.The physician was instructed to pull back on the controller and when the catheter was retracted hemorrhaging was observed from the biopsied lobe.The physician believed the cause of bleeding was due to the catheter issue.The physician administered unspecified medication via an endoscope to control the bleeding.There was a delay of about 30 minutes, but the bleeding was solved.An x-ray was performed and per the physician, it was a moderate amount of bleeding in the biopsied lobe (unspecified).The physician did not remember the exact amount of blood loss, but stated no transfusion was required.The physician did a follow-up computed tomography (ct) scan to decide if the patient would need to stay in the hospital overnight - the patient was observed and discharged home.Per the physician, there were no other issues with the ion system.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has not received a product for failure analysis evaluation.No site visit was conducted; the field service engineer (fse) was informed that there were no issues with two following cases.
Additional Manufacturer Narrative
Additional information: a review of the system logs revealed the user was articulating the trackball during retraction, preventing the catheter from going limp.There was no malfunction observed during log review.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: ION
• Common Device Name: CATHETER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 22158623
• Report Number: 2955842-2025-24092
• Device Sequence Number: 18312421
• Product Code: EOQ
• UDI-Device Identifier: 00886874116258
• UDI-Public: (01)00886874116258(10)N/A
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K212048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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 Model Number: 490105-11
• Device Catalogue Number: 490105
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ION ENDOLUMINAL SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown