MAUDE Adverse Event Report: PHILIPS VOLCANO VISIONS PV .018 CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 86700

Device Problem Material Separation (1562)

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

Event Date 08/10/2022

Event Type  Injury  

Event Description

It was reported that during a diagnostic peripheral procedure, the visions pv.018 catheter worked perfectly.During removal, the distal tip separated near the puncture site.The patient was sedated with local anesthesia and a one (1) cm incision was made in the right arm.Dissection by planes were performed to explore the right basilica vein, and was able to retrieve the distal tip.Images confirmed no piece was retained inside the patient.The patient was discharged the same day as expected with no injury reported.This adverse event and product problem is being submitted due to the tip separation requiring surgical intervention.

Manufacturer Narrative

This complaint was reviewed and investigated according to the manufacturer¿s policy.Initial reporter & report source: (b)(6).The visions pv.018 catheter was discarded by the facility, 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.

• Brand Name: VISIONS PV .018 CATHETER
• 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: ayse yarimoglu ; 3721 valley centre drive #500; san diego, CA 92130
• MDR Report Key: 15254771
• MDR Text Key: 298197470
• Report Number: 3008363989-2022-00068
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00184360000037
• UDI-Public: (01)00184360000037(11)211018(17)231018(10)0302413761
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K150442
• 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: 08/18/2022

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: 10/18/2023
• Device Model Number: 86700
• Device Catalogue Number: 400-0200.285
• Device Lot Number: 0302413761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/12/2022
• Initial Date FDA Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• 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: ABBOTT: 0.018" HI-TORQUE COMMAND GUIDEWIRE; MFG UNK: 6F INTRODUCER SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female