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 09/28/2021

Event Type  malfunction  

Event Description

It was reported that during a diagnostic peripheral procedure, upon removal of the manufacturer's catheter, it was noticed that a piece of the catheter was broken, but remained attached to the guide wire.The procedure was completed with a new device.No patient injury reported.This product problem is being submitted due to a broken device.There is a potential for harm if the malfunction were to recur.

Manufacturer Narrative

This case was reviewed and investigated according to the manufacturer¿s policy.The visions pv.018 catheter has not been returned for evaluation, thus no returned product investigation was performed.

Manufacturer Narrative

Block d9 & h3: visions pv.018 catheter was returned for evaluation block h3: the visions pv.018 catheter was visually and microscopically inspected.A portion of the catheter tip was returned broken and detached from the device.No missing material was observed on the catheter.Block h6: the probable cause of the reported failure is damage in use.Strain, impact, and forces associated with handling may affect the integrity of the device.

• 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 par; b37; alajuela ; CS
• Manufacturer Contact: danielle bullock ; 3721 valley centre drive; #500; san diego, CA 92130
• MDR Report Key: 12635612
• MDR Text Key: 281670937
• Report Number: 3008363989-2021-00018
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00184360000037
• UDI-Public: (01)00184360000037(11)210715(17)230715(10)0302340840
• Combination Product (y/n): Y
• 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: 09/28/2021

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: 07/15/2023
• Device Model Number: 86700
• Device Catalogue Number: 400-0200.285
• Device Lot Number: 0302340840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2021
• Initial Date FDA Received: 10/14/2021
• Supplement Dates Manufacturer Received: 10/29/2021
• Supplement Dates FDA Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2021
• 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: UNK MFG AND SIZE: GUIDEWIRE; UNK MFG AND SIZE: SHEATH
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian