MAUDE Adverse Event Report: PHILIPS VOLCANO VISIONS PV .035 (NON-HOSPITAL); CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	81234
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Not applicable for this device.Not applicable for this device.The visions pv.035 catheter was not returned for evaluation, thus no returned product investigation was performed.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 therapeutic peripheral procedure, while advancing the visions pv.035 catheter to the iliac artery, the tip of the catheter separated in two pieces.Attempts to snare/jail the separated tip was unsuccessful.The tip was left free floating and retained in the pulmonary artery.The patient was transferred to another hospital where it was determined unsafe to retrieve the tip.The patient's condition today is stable.This adverse event and product problem is being submitted due to the tip separation.Additional intervention was unsuccessful, thus was retained in the patient.
Additional Manufacturer Narrative
D9 & h3: visions pv was returned for evaluation.H3: the visions pv was returned without the distal portion of the catheter.Measurements confirmed that approx.6.5 mm of the scanner body and approx.12 mm of the distal tip separated from the catheter.H6: the probable cause of the observed failure is damage during use.Strain, impact, and forces associated with use can affect the integrity of the device.

• Brand Name: VISIONS PV .035 (NON-HOSPITAL)
• 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: danielle bullock ; 3721 valley centre drive #500; san diego, CA 92130
• MDR Report Key: 14704432
• Report Number: 3008363989-2022-00048
• Device Sequence Number: 19377124
• Product Code: OBJ
• UDI-Device Identifier: 00845225002596
• UDI-Public: (01)00845225002596(11)220405(17)240405(10)0302565836
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K153094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2022

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: 04/05/2024
• Device Model Number: 81234
• Device Catalogue Number: 400-0200.272
• Device Lot Number: 0302565836
• 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: 05/25/2022
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2022
• 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: CORDIS: 8F BRITE TIP INTRODUCER SHEATH.; MERIT: 0.035" J-TIP GUIDE WIRE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White