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 06/29/2022

Event Type  malfunction  

Manufacturer Narrative

This case was reviewed and investigated according to the manufacturer¿s policy.Weight & thnicity: no information available.Implant date & explant date: not applicable for this device.Initial reporter name and address & initial reporter health professional: country is germany.The visions pv catheter was not 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 in a slightly calcified proximal sfa, while removing the visions pv.018 catheter, the distal tip separated and was stuck on the non-manufacturer''s guidewire.The catheter and guidewire were removed as a unit with no additional intervention performed.No piece of the catheter was retained in the patient.The procedure was completed with the suspect device with no patient injury reported.This product problem is being submitted because the visions distal tip separated.There is a potential for harm if the malfunction were to recur.

Manufacturer Narrative

Blocks d9 & g3: the visions pv.018 was returned for evaluation.Block h3: the visions pv.018 was returned with a portion of the tip missing.Visual inspection found approximately 3 mm of the tip was intact and approximately 9 mm of the tip was not returned.Block h6: the probable cause of the observed failure is damage during use.Strain, impact, and forces associated with use can affect the integrity of the device.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.

• 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
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone &business park; b37; alajuela ; CS
• Manufacturer Contact: paulette nicole montes ; 3721 valley centre drive #500; san diego, CA 92130
• MDR Report Key: 14957871
• MDR Text Key: 304509897
• Report Number: 3008363989-2022-00058
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00184360000037
• UDI-Public: (01)00184360000037(11)210211(17)230211(10)0302167926
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K150442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/08/2022

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: 02/11/2023
• Device Model Number: 86700
• Device Catalogue Number: 400-0200.285
• Device Lot Number: 0302167926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 07/27/2022
• Supplement Dates FDA Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2021
• 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: 6F INTRODUCER SHEATH MFG UNK; TERUMO: 0.018" GUIDEWIRE
• Patient Age: 70 YR
• Patient Sex: Female