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 08/13/2021

Event Type  Injury  

Manufacturer Narrative

This complaint was reviewed and investigated according to the manufacturers policy.The visions pv catheter has not been returned for evaluation, thus no returned product investigation was performed.

Event Description

It was reported that during a peripheral procedure inside the body in a moderately calcified mid sfa, the manufacturer's catheter was advanced over a non-manufacturer's wire through a non-manufacturer's sheath with no issues.During pullback, resistance was met and upon removal, the distal tip of the manufacturer's catheter broke inside the patient.X-ray confirmed 10cm of the distal tip was left in the distal sfa.Through antegrade access using a non-manufacturer 6f sheath, a snare was used to retrieve the distal tip.Following successful removal, the procedure was completed with the planned atherectomy and angioplasty.The patient is reportedly in good condition.This adverse event and product problem is being submitted due to the tip separation requiring intervention (snare).

Manufacturer Narrative

Block d9: visions pv.014p rx catheter was returned for evaluation.Block h3: the visions pv.014p rx catheter was visually and microscopically inspected.The catheter was separated in two parts; one part has broken microcables and other part has broken and exposed microcables with sharp edges of non malleable material.There were bends and kinks along the catheter shaft and a tear was observed from the guide wire exit port to the distal shaft.Additionally, the core wire was exposed resulting in a sharp edge of non malleable material.No missing material was observed.Block h6: the probable cause of the reported failure is damage in use.Strain, impact, and forces associated with handling may affect the integrity of the device.

• Brand Name: VISIONS PV .014P RX
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): PHILIPS VOLCANO; 3721 valley centre drive; #500; san diego CA 92130
• MDR Report Key: 12436317
• MDR Text Key: 270321136
• Report Number: 3008363989-2021-00011
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002848
• UDI-Public: (01)00845225002848(11)210522(17)230522(10)0302273836
• Combination Product (y/n): Y
• PMA/PMN Number: K152829
• 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: 08/13/2021

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: 05/22/2023
• Device Model Number: 014R
• Device Catalogue Number: 400-0200.297
• Device Lot Number: 0302273836
• 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: 08/13/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 10/12/2021
• Supplement Dates FDA Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBOTT: 0.014" COMMAND GUIDE WIRE.; COOK MEDICAL: 7F BALKIN GUIDING SHEATH.
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR