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 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.No information available.All reasonably known patient information is included in this report.No information available.Not applicable for this device.Not applicable for this device.The record's reportability decision was incorrectly documented, resulting in a late mdr.The visions pv.018 catheter was visually and microscopically inspected.The distal tip of the catheter was separated in two parts with rough edges observed.One of the separated part (10 mm) was intact to the non-manufacturer's's guide wire.The probable cause of the reported tip separation is damage in use.Strain, impact, and forces associated with handling may affect the integrity of the device.Do not apply to this submission.

Event Description

It was reported that during a peripheral procedure during removal from a 7f introducer sheath, the manufacturer's catheter tip separated, but still intact to the non-manufacturer's's guide wire, thus were removed as a unit.No piece was left inside the patient.The procedure was completed with a new device.No patient injury reported.This product problem is being submitted because a distal tip separation has a potential for harm if the malfunction were to recur.

• Brand Name: VISIONS PV .018 CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone & business par; b37; alajuela ; CS
• Manufacturer Contact: ana tan ; 2870 kilgore road; rancho, CA 95670
• MDR Report Key: 11988081
• MDR Text Key: 255981679
• Report Number: 2939520-2021-00044
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00184360000037
• UDI-Public: (01)00184360000037(11)200926(17)220926(10)0302043176
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2020

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: 09/26/2022
• Device Model Number: 86700
• Device Catalogue Number: 400-0200.285
• Device Lot Number: 0302043176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 06/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2020
• 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
• Patient Age: 81 YR