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

Model Number 81234

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/25/2022

Event Type  Injury  

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 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.

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)
• 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 park; b37; alajuela ; CS
• Manufacturer Contact: danielle bullock ; 3721 valley centre drive #500; san diego, CA 92130
• MDR Report Key: 14704432
• MDR Text Key: 294871972
• Report Number: 3008363989-2022-00048
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002596
• UDI-Public: (01)00845225002596(11)220405(17)240405(10)0302565836
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153094
• 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,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 06/15/2022
• Supplement Dates Manufacturer Received: 06/22/2022
• Supplement Dates FDA Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2022
• 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: CORDIS: 8F BRITE TIP INTRODUCER SHEATH.; MERIT: 0.035" J-TIP GUIDE WIRE.
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White