MAUDE Adverse Event Report: VOLCANO CORPORATION EAGLE EYE PLATINUM RX DIGITAL IVUS CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	85900P
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Blocks a2-a5: no information available.Blocks b6 & b7: no information available.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Blocks h3 & h6: the eagle eye platinum catheter was discarded by the facility, thus no returned product investigation was performed.Blocks h7 & h9: do not apply to this submission.Submission of this report does not, in itself, represent a conclusion by the manufacturer and / or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and / or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
Event or Problem Description
It was reported that an eagle eye platinum catheter was used in a diagnostic peripheral procedure in the left proximal iliac artery.During use, the catheter was unable to advance past the left iliac artery.During pull back, the tip broke off inside the patient.However, the separated portion was successfully removed with a snare.No patient injury reported.This adverse event and product problem is being submitted due to the tip separation and additional intervention (stent).
Additional Manufacturer Narrative
Blocks a2/a3/g2: patient information obtained from user facility report.Block b5: stent was corrected to snare.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
Event or Problem Description
This adverse event and product problem is being submitted due to the tip separation and additional intervention (snare).
Additional Manufacturer Narrative
Blocks d9 & h3: the initial mdr stated the catheter was discarded.However, the eagle eye catheter was not discarded, but was returned for evaluation.Block h3: the eagle eye catheter was returned in two pieces.Visual inspection found the catheter separated at the distal shaft and not the distal tip.At the location of separation, the microcables and the core wire were exposed, resulting in sharp edges observed.No missing material was detected.Block h6: the probable cause of the separated distal shaft is damage during removal/handling.Strain, impact, and forces associated with use can affect the integrity of the device.Based on device evaluation, the component code 3123- tip that was reported in the initial was updated to 4721- rod/shaft.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

• Brand Name: EAGLE EYE PLATINUM RX DIGITAL IVUS CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): VOLCANO CORPORATION; 3721 valley centre drive #500; san diego CA 92130
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone &business park; b37; alajuela ; CS
• Manufacturer Contact: danielle bullock ; 3721 valley centre drive #500; san diego, CA 92130 ; 619633-4179
• MDR Report Key: 17569072
• Report Number: 3008363989-2023-00038
• Device Sequence Number: 2429713
• Product Code: OBJ
• UDI-Device Identifier: 00845225001278
• UDI-Public: (01)00845225001278(11)230317(17)250317(10)0302854372
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K143701
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/08/2024

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: 03/17/2025
• Device Model Number: 85900P
• Device Catalogue Number: 85900P
• Device Lot Number: 0302854372
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 09/26/2023; 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK MFG AND SIZE: GUIDEWIRE.; UNK MFG: 6F INTRODUCER SHEATH.
• Patient Age: 77 YR
• Patient Sex: Male