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

Model Number	88901
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 11646205
• Report Number: 2939520-2021-00016
• Device Sequence Number: 3052649
• Product Code: OBJ
• UDI-Device Identifier: 00845225002329
• UDI-Public: (01)00845225002329(17)220731(10)0301983175(90)989609000491
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K150442
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 06/06/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1