MAUDE Adverse Event Report: PHILIPS VOLCANO VISIONS PV .014P RX; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 014R

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/14/2022

Event Type  Injury  

Manufacturer Narrative

This case was reviewed and investigated according to the manufacturer¿s policy.The visions pv.014p rx catheter was returned without the distal tip, distal and proximal fillets, scanner body, a portion of the distal shaft and three marker bands.The received portion of the catheter was visually and microscopically inspected.The core wire and broken micro-cables were exposed and sharp edges of non-malleable material were observed.The probable cause is damage in use.Strain, impact, and forces associated with handling may affect the integrity of the device.Per the ifu precautions, if resistance is encountered during pullback, remove the entire system (guide wire, ivus catheter, sheath/guide catheter) at the same time.

Event Description

It was reported that during a therapeutic peripheral procedure, upon removal, resistance was encountered and the manufacturer's catheter separated at the distal end.The physician attempted to use a buddy wire and a larger catheter to remove the separated potion but was unsuccessful.It was decided to leave the separated portion, unstented, in the side branch or collateral of the sfa.The patient was discharged as expected.This adverse event and product problem is being submitted because the distal portion of the manufacturer's catheter separated in the patient and additional intervention was performed unsuccessfully.The separated portion was retained in the patient.

• Brand Name: VISIONS PV .014P RX
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; san diego CA 92130
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone & business par; b37; alajuela ; CS
• Manufacturer Contact: in young rock ; 3721 valley centre drive; #500; san diego, CA 92130
• MDR Report Key: 13735699
• MDR Text Key: 287026268
• Report Number: 3008363989-2022-00013
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002848
• UDI-Public: (01)00845225002848(11)220102(17)240102(10)0302486280
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152829
• 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
• Report Date: 02/14/2022

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: 01/02/2024
• Device Model Number: 014R
• Device Catalogue Number: 400-0200.297
• Device Lot Number: 0302486280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2022
• 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: ABBOTT: 0.014" BALANCE MIDDLEWEIGHT GUIDEWIRE; CARDINAL HEALTH: 6F BRITE TIP INTRODUCER SHEATH
• Patient Outcome(s): Required Intervention