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

Model Number 86700

Device Problem Material Separation (1562)

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

Event Date 07/30/2021

Event Type  malfunction  

Manufacturer Narrative

This complaint was reviewed and investigated according to the manufacturer¿s policy.The visions pv.018 catheter has not been returned for evaluation, thus no returned product investigation was performed.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

Event Description

It was reported that during a peripheral procedure, the manufacturer's catheter tip separated and was removed along with the guidewire and sheath.No additional intervention was needed to remove the separated portion and all pieces of the device were accounted for.The procedure was completed with a new manufacturer's catheter.No patient injury reported.This product problem is being submitted because a distal tip separation has a potential for harm if the malfunction were to recur.

Event Description

It was reported that during a peripheral procedure, the manufacturer's catheter tip separated and was removed along with the guidewire.No additional intervention was needed to remove the separated portion and all pieces of the device were accounted for.The procedure was completed with a new manufacturer's catheter.No patient injury reported.

Manufacturer Narrative

Block b5: updated from removal with the sheath and guidewire to removal with just the guidewire.Blocks d9: the visions pv.018 catheter was returned for evaluation.Blocks h3: the visions pv.018 catheter was visually inspected and confirmed a portion of the catheter tip was detached and missing.Block h6: the probable cause of the reported failure is damage in use.Strain, impact, and forces associated with use can affect the integrity of the device.

• Brand Name: VISIONS PV .018 CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 3721 valley centre drive; #500; san diego CA 92130
• MDR Report Key: 12345445
• MDR Text Key: 267471181
• Report Number: 3008363989-2021-00008
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00184360000037
• UDI-Public: (01)00184360000037(11)210608(17)230608(10)0302294748
• 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: 07/30/2021

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: 06/08/2023
• Device Model Number: 86700
• Device Catalogue Number: 400-0200.285
• Device Lot Number: 0302294748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/19/2021
• Supplement Dates Manufacturer Received: 10/12/2021
• Supplement Dates FDA Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK: 0.018" BENTSON GUIDEWIRE; MERIT: ULTRA FLUSH GUIDE CATHETER SIZE UNK; TERUMO: 6F DESTINATION INTRODUCER SHEATH