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

Model Number	85900PST
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Weight: no information available.Relevant tests/history: no information available.Implant/explant date: not applicable for this device.The eagle eye platinum st catheter was not returned for evaluation, thus no returned product investigation was performed.Recall: 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 during a diagnostic peripheral procedure, resistance was encountered during insertion of the eagle eye platinum st catheter within the upper right arm extremity.When the physician attempted to pullback the catheter, more resistance was encountered.Ultimately, the catheter sheered and the distal tip separated from the catheter.The proximal portion of the catheter was removed and the 0.014¿ non-manufacturer guide wire was bent.The separated tip was removed with a snare and a full body fluoroscopy confirmed no piece was retained inside the patient.The patient was discharged as expected in good condition.This adverse event and product problem is being submitted due to the tip separation requiring intervention (snare).
Additional Manufacturer Narrative
Block h3: the eagle eye platinum st catheter was returned in two pieces.The catheter separated at the distal shaft approximately 185 mm from the tip (includes distal tip, distal and proximal fillets, scanner body, and a portion of the distal shaft).Under visual and microscopic inspection, the microcables and inner member were exposed with rough edges of malleable material.Additionally, the core wire was exposed with a sharp edge.There was no missing material, all portions of the catheter was accounted for.Block h6 correction: component code updated from 3123 (tip) to 4721 (rod/shaft).Based on the device evaluation, the distal shaft separated and not the distal tip.Block h6: the probable cause of the shaft separation is damage during use and handling.Strain, impact, and forces associated with use can affect the integrity of the device.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 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 park; b37; alajuela ; CS
• Manufacturer Contact: ayse yarimoglu ; 3721 valley centre drive #500; san diego, CA 92130
• MDR Report Key: 14347478
• Report Number: 3008363989-2022-00027
• Device Sequence Number: 12014352
• Product Code: OBJ
• UDI-Device Identifier: 00845225002312
• UDI-Public: (01)00845225002312(11)211213(17)231213(10)0302477134
• 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,Followup
• Report Date (Section B): 07/14/2022

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: 12/13/2023
• Device Model Number: 85900PST
• Device Catalogue Number: 400-0200.141
• Device Lot Number: 0302477134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/13/2022
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2021
• 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: ASAHI: 0.014 GLADIUS GUIDEWIRE; TERUMO: 6FR DESTINATION INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White