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

Model Number	85900PST
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Blocks a2, a4 & a5: no information available.Blocks b6 & b7: no information available.Block c: not applicable for this device.Block h3: the eagle eye platinum st catheter was returned with only the proximal portion (includes proximal shaft, luer connector, the connector cable, and a portion of distal shaft) which measured at approximately 144.5 cm.Visual inspection at the location of separation found the microcables and core wire were exposed with sharp edges observed.The overall catheter working length is 150 +/- 2.5 cm which concludes that approximately 5.5 cm of the distal portion (includes distal tip, distal fillet, scanner body, proximal fillet) was not returned.Although 5.5 cm (55 mm) was not accounted for during device evaluation, it was confirmed that only 2 mm was retained in the patient.Block h6: the probable cause of the reported failure is damage during use.Device manipulation, impact and applied pressure associated with use and handling can further affect the integrity of the device.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 st was used in a therapeutic peripheral procedure in the tibial artery and superficial femoral artery.During pullback, the distal tip separated in the mid popliteal, measuring approximately 2 mm in length.The separated distal tip was stented to the vessel wall.This adverse event and product problem is being submitted because the distal tip separated inside the patient.Additional intervention was performed; however, the distal tip was retained in the patient (stent).

• Brand Name: EAGLE EYE PLATINUM ST 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: ayse kharodawala ; 3721 valley centre drive #500; san diego, CA 92130 ; 858720-4063
• MDR Report Key: 18105802
• Report Number: 3008363989-2023-00049
• Device Sequence Number: 5556164
• Product Code: OBJ
• UDI-Device Identifier: 00845225002312
• UDI-Public: (01)00845225002312(11)230912(17)250912(10)0302994107
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120697
• 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
• Report Date (Section B): 11/09/2023

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: 09/12/2025
• Device Model Number: 85900PST
• Device Catalogue Number: 85900PST
• Device Lot Number: 0302994107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6F, TERUMO DESTINATION INTRODUCER SHEATH; TERUMO ADVANTAGE GUIDEWIRE SIZE UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female