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

Model Number 014R

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).This case was reviewed and investigated according to the manufacturer¿s policy.Attempts to obtain patient information have been unsuccessful.Attempts to obtain the patient information were made via email.All reasonably known patient information is included in this report.No information available.The implant or explant dates are not applicable to this device.Not applicable for this device.Concomitant medical products: no information available.The returned device was visually and microscopically inspected.The scanner body and distal floppy tip were separated from the distal shaft and not returned for investigation.The edges of the damaged distal shaft were irregular, portions were stretched, missing and torn off with the scanner body.The probable cause of the reported failure is mechanical strain, as evidenced by the stretched material observed at the damaged portion of the distal shaft.However, it was not possible to conclusively determine how the failure occurred.Recall: do not apply to this submission.The instructions for use (ifu) cautions: prior to use, carefully inspect the scanner and catheter body for bends, kinks or other damage.Do not use a damaged or suspected damaged catheter.Protect the catheter tip from impact and excessive force.Do not advance the guide wire against significant resistance.If binding occurs between the catheter and the guide wire while inside the patient, carefully remove both the wire and catheter and do not use.The catheter should never be forcibly inserted into lumens narrower than the catheter body or forced through a tight stenosis.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.

Event Description

It was reported during a peripheral therapeutic procedure inside the body advancing to the lesion, the tip of the manufacturer¿s device broke off and was retrieved using a snare.A new device was used to complete the procedure.Patient was discharged as expected.Vessel tortuosity: moderate.This adverse event is being submitted because additional intervention was required to remove the manufacture's device.

• Brand Name: VISIONS PV .014P RX
• 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 park; b37; alajuela ; CS
• Manufacturer Contact: melissa mangum ; 2870 kilgore road; rancho cordova, CA 95670 ; 8584650468
• MDR Report Key: 10732007
• MDR Text Key: 216642787
• Report Number: 2939520-2020-00032
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002848
• UDI-Public: (01)00845225002848(17)220731(10)0301989103(90)989609001091
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K152829
• 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: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 0301989103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2020
• 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 Outcome(s): Required Intervention