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

Model Number 86700J

Device Problem Material Separation (1562)

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

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

This case was reviewed and investigated according to the manufacturer¿s policy.Country is (b)(6).The probable cause of the missing shaft material is damage in use.Device manipulation, impact, and applied pressure associated with use and handling can further affect the integrity of the device.

Event Description

It was reported that during a peripheral procedure inside the body while passing through the sfa, the manufacturer's catheter lost image.The procedure was completed with a new manufacturer's catheter.No patient injury reported.The returned device was visually and microscopically inspected and found a portion of the distal shaft material missing.This product problem is being submitted because a portion of the manufacturer's distal shaft was missing.There is a potential for harm if the malfunction were to recur.

• Brand Name: VISIONS PV .018
• 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 par; b37; alajuela ; CS
• Manufacturer Contact: ana tan ; 3721 valley centre drive; #500; san diego, CA 92130
• MDR Report Key: 12264163
• MDR Text Key: 265180734
• Report Number: 3008363989-2021-00005
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002794
• UDI-Public: (01)00845225002794(17)221109(10)0302078687(90)989609001011
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K150442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2022
• Device Model Number: 86700J
• Device Catalogue Number: 400-0200.285
• Device Lot Number: 0302078687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/05/2021
• Initial Date FDA Received: 08/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2020
• 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