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

Model Number	86700
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• 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: 15254771
• Report Number: 3008363989-2022-00068
• Device Sequence Number: 5886753
• Product Code: OBJ
• UDI-Device Identifier: 00184360000037
• UDI-Public: (01)00184360000037(11)211018(17)231018(10)0302413761
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K150442
• 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): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• 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: ABBOTT: 0.018" HI-TORQUE COMMAND GUIDEWIRE; MFG UNK: 6F INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female