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 03/08/2021

Event Type  malfunction  

Manufacturer Narrative

Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturers policy.Pt info: no information available.Add'l tests: not applicable for this device.The implanted or explanted dates are not applicable to this device.Device returned for eval: not applicable for this device.Country is (b)(6).The probable cause for the missing material at the distal tip may be due to handling.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.(b)(4).Recall: do not apply to this submission.

Event Description

It was reported that during a therapeutic peripheral procedure, the manufacturer's device received an error message of "catheter fault detected".A new manufacturer's device was used to complete the procedure successfully.No patient injury reported.The returned device was visually and microscopically inspected and evidence of missing material was noted at the distal tip.This product problem is being submitted because a portion of the manufactured's device was missing.There is a potential for harm if the malfunction were to recur.

Manufacturer Narrative

Internal reference: (b)(4).Block h6: added code 3123 (tip) and 2199 (no health consequences or impact).

• Brand Name: VISIONS PV .014P RX
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 11761196
• MDR Text Key: 249212811
• Report Number: 2939520-2021-00023
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002848
• UDI-Public: (01)00845225002848(17)220731(10)0301993341(90)989609001091
• Combination Product (y/n): Y
• PMA/PMN Number: K152829
• 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: 03/08/2021

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: 014R
• Device Catalogue Number: 400-0200.297
• Device Lot Number: 0301993341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/06/2021
• Initial Date FDA Received: 05/03/2021
• Supplement Dates Manufacturer Received: 06/06/2021
• Supplement Dates FDA Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK MFG AND SIZE: GUIDE CATHETER; UNK MFG AND SIZE: GUIDE WIRE; UNK MFG AND SIZE: INTRODUCER SHEATH