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

Model Number 014R

Device Problem Material Separation (1562)

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

Event Date 12/22/2021

Event Type  malfunction  

Manufacturer Narrative

This complaint was reviewed and investigated according to the manufacturer¿s policy.Device: not applicable for this device.Implant/explant date: not applicable for this device.The visions pv.014 catheter has not been returned for evaluation, thus no returned product investigation was performed.Do not apply to this submission.

Event Description

It was reported that during a therapeutic peripheral procedure, the manufacturer's catheter got stuck to the non-manufacturer¿s guidewire.Therefore, it was attempted to be removed as a system.However, as the physician pulled on the catheter, he felt a snap and it broke in two pieces.The proximal end of the catheter was removed alone, while the distal end was removed intact to the guidewire.No piece of the catheter was retained in the patient.The procedure was completed with the suspect catheter and no patient injury was reported.This product problem is being submitted because the manufacturer's catheter shaft broke in two pieces.There is a potential for harm if the malfunction were to recur.

Manufacturer Narrative

Block d9 & h3: visions pv catheter was returned for evaluation.Block h3: the visions pv catheter was visually and microscopically inspected.The device was returned in two pieces where the distal shaft separated from the rx bond.Measurement of the distal shaft confirmed that 5mm of shaft material was missing.At the distal shaft, the inner member was bunched up and exposed with rough edges of malleable material.There were portions of adhesive lifted and missing at the proximal fillet.At the proximal shaft, coiling was observed and the micro cables were broken/exposed with rough edges of malleable material.The core wire was also exposed, resulting in sharp edges of non-malleable material.Block h6: the probable cause of the reported failure is damage in use as evidenced by the device separation.Device manipulation, impact, and applied pressure associated with handling can further affect the integrity of the device.

Manufacturer Narrative

Block g: updated the city from (b)(6).Updated the country from united states (usa) to costa rica (cri).

• Brand Name: VISIONS PV .014P RX
• 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: 13311598
• MDR Text Key: 287400329
• Report Number: 3008363989-2022-00004
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002848
• UDI-Public: (01)00845225002848(11)211023(17)231023(10)0302430506
• 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,Followup,Followup
• Report Date: 12/28/2021

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: 10/23/2023
• Device Model Number: 014R
• Device Catalogue Number: 400-0200.297
• Device Lot Number: 0302430506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2021
• Initial Date FDA Received: 01/20/2022
• Supplement Dates Manufacturer Received: 02/02/2022; 04/07/2022
• Supplement Dates FDA Received: 02/25/2022; 04/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2021
• 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: ASAHI: 0.014" MONGO GUIDEWIRE.; TERUMO: 7F DESTINATION INTRODUCER SHEATH.
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White