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 11/28/2022

Event Type  Injury  

Event Description

It was reported that a visions pv.018 catheter was used in a diagnostic peripheral procedure in the sfa.During pullback, resistance was encountered and the catheter got stuck on a non-philips wire.As a result, the catheter distal tip separated (includes imaging core), but was successfully retrieved using a snare.Angio and xray confirmed no piece of the catheter was left in the patient.The patient was discharged as expected.This adverse event and product problem is being submitted due to the visions distal tip separation, requiring intervention (snare).

Manufacturer Narrative

This complaint was reviewed and investigated according to the manufacturer¿s policy.Suspect product: not applicable for this device.Implant and explant date: not applicable for this device.Device evaluation by manufacturer: the visions pv.018 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.

Manufacturer Narrative

Block h3: the visions pv.018 catheter was visually and microscopically inspected.The distal portion of the catheter was not returned (distal tip, distal fillet, scanner body, and expanded single lumen).Visual inspection of the returned returned portion of the catheter found a zipper tear at the guide wire exit port that extended up to where the device had separated.Additionally, the broken microcables were exposed with sharp edges observed.Block h6 correction: based on the device evaluation, the catheter separated at the distal shaft and not the distal tip; therefore, component code was updated from "3123" to "4721".Block 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.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: 16010400
• MDR Text Key: 305786329
• Report Number: 3008363989-2022-00078
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150442
• 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: 01/17/2023

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 Model Number: 86700
• Device Catalogue Number: 400-0200.285
• Device Lot Number: 0302720684
• 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: 11/28/2022
• Initial Date FDA Received: 12/19/2022
• Supplement Dates Manufacturer Received: 11/28/2022
• Supplement Dates FDA Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2022
• 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: PROWATER GUIDE WIRE SIZE UNK; TERUMO: 6F INTRODUCER SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White