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

Model Number 85900PST

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/13/2023

Event Type  Injury  

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 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
• Type of Device: 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 ; 858720-406
• MDR Report Key: 18105802
• MDR Text Key: 327881991
• Report Number: 3008363989-2023-00049
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002312
• UDI-Public: (01)00845225002312(11)230912(17)250912(10)0302994107
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 6F, TERUMO DESTINATION INTRODUCER SHEATH; TERUMO ADVANTAGE GUIDEWIRE SIZE UNK
• Patient Outcome(s): Required Intervention
• Patient Sex: Female