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

Model Number 490105-11

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2022

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the catheter instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigations replicated/confirmed the customer reported complaint.Fa found the primary failure of the missing distal tip ring to be related to the customer complaint.For clarification, visual inspection of the catheter instrument found the golden ring that is located within the tubing at the distal tip was missing from the catheter.An in-house catheter was used to compare visual differences and confirmed the ring was missing from the reported instrument.The ring was not returned with the instrument, however, based on follow up information, it was confirmed that the missing ring was retrieved and discarded by the user.Therefore, no potential fragments were reported.Visual inspection of the fibers in the sensor connector were smooth and showed no signs of damage.No fluid or residue was observed in the housing or the tool channel when shaken vigorously.No external physical damages were observed at the proximal end of the instrument.The instrument had no uses remaining.The root cause for this failure is not established and will be transferred to engineering for further review, the verification of the event details cannot be performed via system logs because system logs did not exist.Isi has received the images of the broken catheter instrument.The review of the provided image is conducted by the isi failure analysis engineer (fae) and found the following additional information: the catheter tip ring appeared to be dislodged.From the images provided, the root cause is not determinable.However, the device investigation is in progress to determine the cause of the tip ring dislodgement.This complaint is being reportable malfunction and adverse event based on the following: it was alleged that the screw that had fallen off the forceps or the catheter and fell into the patient during procedure.It was removed from the patient during the procedure.

Event Description

It was reported that during an ion endobronchial lung biopsy procedure, the system had a ring displayed in the image.The customer removed the vision probe, reinserted.And the issue remained same.An endoluminal sales representative (esr) recommended the customer to get a backup vison probe and while they were waiting for the backup, the physician elected to continue and navigate to the target.While the customer was navigating, the esr suggested that the catheter could be the issue.The customer navigated to the target, switched to a backup vision probe and the issue remained.The customer elected to continue and installed the forceps.While inserting the forceps, the customer noted a screw that had fallen off the forceps or the catheter and fell into the patient.The customer confirmed the presence of the screw under fluoro and retrieved the screw.The esr stated that while inserting the vison probe, the probe extended past the tip of the catheter.The diagnostic procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information on 31-august-2022: all fragment(s) were retrieved by using the forceps.The catheter ring could be seen under flouro and then could see the forceps grab and pull it out also, the catheter tip was fully present, and no part was missing.The surgeon believed the catheter was the problem.An esr believed there was damage to the catheter during transport but not fully sure.The catheter was on its last life so it was used 4 other times.The issue occurred during biopsy forceps after multiple needles passes and other forceps passes.There was no patient injury.Isi followed up with the physician and obtained the following additional information on 15-september-2022: when the customer started the procedure and inserted the vp, the image looked unusual, somehow different.The customer proceeded anyway with the registration which was ok.After navigating to the target area, the surgeon pulled out the vp and replaced with a biopsy forceps for tissue retrieval and suddenly noticed a foreign body on the fluoroscopic image.The surgeon retrieved the foreign body within seconds and identified it as a metal ring on the back table.There were no problems inserting the vp or the forceps through the catheter.Subsequently, the customer realized that the metal ring was part of the catheter and removed and replaced the catheter with a new one.The procedure was completed and the patient did not experience any adverse events during or after the procedure.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the catheter involved with this complaint and completed the device evaluation.Advance failure analysis (afa) investigation replicated/ confirmed the customer reported complaint.The catheter had an ovalized tip with a ratio of major to minor diameter of 1.2.The instrument was ovalized after the 4th use and before the 5th use when a visual of gold ring was seen with the vision probe (vp).The solder on the control ring was cracked in the deformed areas of the ring along the major axis.No solder delamination was observed with the exception of the crack sites.No evidence of lack of solder wicking, excess pebax or plating delamination was found on the device.The load required to ovalize catheter tips to a 1.2 ratio was between 14.5 - 31 lb./ samples that were ovalized and pull tested to failure having values significantly lower than expected value.Samples that had the tips removed also had solder cracked in the same location as the catheter.The primary cause of the tip dislodgment was ovalization of the tip ring.The ovalization caused the solder wicked between the tip ring and control ring to crack and compromised the structural integrity of the solder leading to tip dislodgment.The load required to ovalize the tip ring was estimated to be between 14 - 31 lbf is considered significant and should not have gone unnoticed.These external loads imposed on the tip are considered beyond foreseeable misuse.The failure could be reproduced, but not on a consistent basis, indicating that the level of damage to the catheter tip could play a role.In most test cases, it appears as though the catheter tip is capable of withstand these loads and ovalization without the occurrence of tip dislodgement.Additionally, it is important to note that sem analysis confirmed that the failure was not due to lack of solder wicking, thin solder or void as was found in previous failures documented as part of root cause.The root cause of tip dislodgement is attributed to mishandling/misuse.Based on information provided in the complaint, the dislodged tip ring was retrieved and discarded by the user.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ION
• Type of Device: CATHETER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 15481732
• MDR Text Key: 300576364
• Report Number: 2955842-2022-14206
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 00886874116258
• UDI-Public: (01)00886874116258(10)S12220406
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2022

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
• Device Operator: Health Professional
• Device Model Number: 490105-11
• Device Catalogue Number: 490105
• Device Lot Number: S12220406 0005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2022
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 09/24/2022
• Supplement Dates Manufacturer Received: 12/01/2022
• Supplement Dates FDA Received: 12/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ION ENDOLUMINAL SYSTEM
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian