MAUDE Adverse Event Report: 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 09/07/2021

Event Type  Injury  

Manufacturer Narrative

This complaint was reviewed and investigated according to the manufacturer¿s policy.Relevant tests, lab data, including dates & other relevant history, including preexisting conditions: no information available.Suspect product(s): not applicable for this device.Implant & explant date: not applicable for this device.Device evaluated by mfr & adverse event problem: the visions pv.014p rx catheter has not been returned for evaluation, thus no returned product investigation was performed.Recall & correction/removal number: do not apply to this submission.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 diagnostic peripheral procedure, during removal in the distal sfa, the manufacturer's catheter separated at the transition point of the rapid exchange port.The catheter was lost in the body; thus, the physician performed a cutdown approach to extract the catheter.The procedure was completed through a different access point and the patient was discharged as expected.This adverse event and product problem is being submitted due to the catheter separation requiring surgical intervention.

Manufacturer Narrative

Block d9 & h3: 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, resulting in broken microcables with sharp edges and exposed core wire.The proximal shaft was twisted and a tear was observed at the guidewire exit port.No missing material was detected.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
• MDR Report Key: 12557466
• MDR Text Key: 274924810
• Report Number: 3008363989-2021-00015
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002848
• UDI-Public: (01)00845225002848(11)210805(17)230805(10)0302352559
• 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: 09/07/2021

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: 08/05/2023
• Device Model Number: 014R
• Device Catalogue Number: 400-0200.297
• Device Lot Number: 0302352559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 09/30/2021
• Supplement Dates Manufacturer Received: 10/15/2021
• Supplement Dates FDA Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2021
• 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
• Treatment: TERUMO: 5F INTRODUCER SHEATH.; UNK MFG AND SIZE: GUIDE WIRE.
• Patient Age: 77 YR
• Patient Weight: 79