MAUDE Adverse Event Report: PHILIPS VOLCANO EAGLE EYE PLATINUM ST; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 85900PST

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2021

Event Type  Injury  

Event Description

It was reported that during a therapeutic peripheral procedure in a severely calcified mid sfa, the manufacturer's catheter encountered resistance and could not be advanced or retrieved.Upon removal, the catheter separated and was retrieved using a non manufacturer's micro catheter and non manufacturer's otw balloon catheter.The procedure was completed with another device and the patient was discharged as expected.This adverse event and product problem is being submitted due to the catheter shaft separation, requiring additional intervention to retrieve the separated portion of the catheter.

Manufacturer Narrative

This complaint was reviewed and investigated according to the manufacturer¿s policy.The eagle eye platinum st was visually and microscopically inspected.The device was returned separated in two parts, resulting in sharp edges at the broken microcables and exposed core wire.No missing material was observed.The probable cause of the reported failure is damage in use.Strain, impact, and forces associated with handling may affect the integrity of the device.

• Brand Name: EAGLE EYE PLATINUM ST
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 3721 valley centre drive; #500; san diego CA 92130
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone & business par; b37; alajuela ; CS
• Manufacturer Contact: danielle bullock ; 3721 valley centre drive; #500; san diego, CA 92130
• MDR Report Key: 12815108
• MDR Text Key: 282927658
• Report Number: 3008363989-2021-00021
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002312
• UDI-Public: (01)00845225002312(11)210809(17)230809(10)0302359046
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/20/2021

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 Expiration Date: 08/09/2023
• Device Model Number: 85900PST
• Device Catalogue Number: 400-0200.141
• Device Lot Number: 0302359046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2021
• 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: TERUMO: 6F DESTINATION SHEATH/GUIDE; UNK MFG AND SIZE: GUIDE WIRE
• Patient Outcome(s): Required Intervention