MAUDE Adverse Event Report: PHILIPS VOLCANO VISIONS PV .035 CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 88901

Device Problem Material Separation (1562)

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

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Patient identifier, age or date of birth, sex, weight, and ethnicity: attempts to obtain patient information via email have been unsuccessful.All reasonably known patient information is included in this report.Implant and explant date: the implanted or explanted dates are not applicable to this device.Date received my manufacturer: user facility report #mw5o99400.(b)(4).Recall, or correction/removal number: do not apply to this submission.Attempts to obtain device return information via email have been unsuccessful.

Event Description

It was reported during a diagnostic peripheral cauterization procedure, inside the body while passing through the lesion, the manufacturers device was advanced to the lesion and the tip of the catheter came apart, exposing the bare wire tip.However, the catheter was retrieved in one piece with no additional intervention and no patient harm.The procedure was completed with a new manufacturer's device.

Manufacturer Narrative

Block b5: added reason for reporting a product problem.Block h6: added codes 3123 (tip) and 2199 (no health consequences or impact).

Event Description

This product problem is being submitted because a tip separation has a potential for harm if the malfunction were to recur.

• Brand Name: VISIONS PV .035 CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 11646205
• MDR Text Key: 266982370
• Report Number: 2939520-2021-00016
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002329
• UDI-Public: (01)00845225002329(17)220731(10)0301983175(90)989609000491
• Combination Product (y/n): Y
• PMA/PMN Number: K150442
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

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: 07/31/2022
• Device Model Number: 88901
• Device Catalogue Number: 400-0200.173
• Device Lot Number: 0301983175
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/12/2021
• Initial Date FDA Received: 04/09/2021
• Supplement Dates Manufacturer Received: 06/06/2021
• Supplement Dates FDA Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1