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

Model Number	85900PST
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3008363989-2021-00021
• Device Sequence Number: 5512119
• Product Code: OBJ
• UDI-Device Identifier: 00845225002312
• UDI-Public: (01)00845225002312(11)210809(17)230809(10)0302359046
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2021
• 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: TERUMO: 6F DESTINATION SHEATH/GUIDE; UNK MFG AND SIZE: GUIDE WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown