MAUDE Adverse Event Report: PHILIPS VOLCANO VISIONS PV .018 CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 86700

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 10/05/2020

Event Type  Injury  

Manufacturer Narrative

Internal reference: (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.Additional information obtained indicated during a planned diagnostic peripheral procedure, while advancing through the vessel, the tip of the manufacturer¿s device separated and came off from the tip of the shaft and device broke in half.The physician used a snare to attempt to remove the separated tip of the device.The procedure was completed without use of another catheter device.No damage to the device was observed prior to procedure.The device was never stuck and no resistance was encountered.No parts appeared to be protruding.The device was not returned as the facility did not save the device.Suspect products: no information available.The implant or explant dates are not applicable to this device.Device evaluation: not applicable for this device.Concomitant medical products: no information available.Facility discarded device and it will not be returned.Remedial action and removal #: do not apply to this submission.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 planned diagnostic peripheral procedure inside the body advancing to the lesion, the manufacture¿s catheter device separated from the shaft during use.Patient was released as expected in stable condition.Vessel: av fistula.Vessel segment: mid.Target lesion: soft tissue, no calcification, no tortuosity.This adverse event and product problem is being submitted because additional intervention was required to attempt removal.There is potential for harm if the malfunction were to recur.

Manufacturer Narrative

Block d5: inadvertent omission.Block d10: entry error, device is not available for evaluation.Block d10: entry error, device not returned for analysis.Block h6: entry error, corrected code.

Event Description

This follow-up report #1 is being submitted to correct entry errors in the initial report.

• Brand Name: VISIONS PV .018 CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• MDR Report Key: 10715397
• MDR Text Key: 213173443
• Report Number: 2939520-2020-00030
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00184360000037
• UDI-Public: (01)00184360000037(17)220731(10)0301993383(90)300004659341
• Combination Product (y/n): Y
• PMA/PMN Number: K150442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/06/2020

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: 86700
• Device Catalogue Number: K8886700
• Device Lot Number: 0301993383
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/15/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SHEATH, SNARE.
• Patient Age: 32 YR