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

Model Number 86700J

Device Problem Material Separation (1562)

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

Event Date 05/23/2022

Event Type  malfunction  

Manufacturer Narrative

This complaint was reviewed and investigated according to the manufacturer¿s policy.(b)(6).The visions pv.018 catheter was returned for evaluation; however, the returned product investigation has not begun, thus a supplemental report will be filed upon completion.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 in the cto of the left mid sfa, the pv.018 catheter was inserted from the right femoral artery and passed through the non-manufacturer''s guidewire by the crossover approach to observe the vessel.Then, the catheter was removed to insert a balloon over the guidewire to expand the lesion.While loading the balloon over the guidewire, the catheter distal tip was found separated and stuck on the guidewire.No piece of the catheter was retained in the patient.The procedure was completed without ivus and no patient injury reported.This product problem is being submitted because the distal tip separated.There is a potential for harm if the malfunction were to recur.

Manufacturer Narrative

This complaint was reviewed and investigated according to the manufacturer¿s policy.Block h3: the visions pv.018 was visually and microscopically inspected.The distal tip measured approximately 4 mm in length.Per specification, overall tip measurement length is 12 mm +/- 1 mm; therefore, approximately 8 mm of the distal tip was separated and not returned with the device.Block h6: the probable cause for the separated tip is damage in use.Device manipulation, impact, and applied pressure associated with use and handling can further affect the integrity of the device.It could not be conclusively determined when or how the damage occurred.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
• 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: ayse yarimoglu ; 3721 valley centre drive #500; san diego, CA 92130
• MDR Report Key: 14761007
• MDR Text Key: 302023405
• Report Number: 3008363989-2022-00052
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002794
• UDI-Public: (01)00845225002794(11)220103(17)240103(10)0302486337
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/11/2022

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: 01/03/2024
• Device Model Number: 86700J
• Device Catalogue Number: 400-0200.285
• Device Lot Number: 0302486337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 06/21/2022
• Supplement Dates Manufacturer Received: 06/22/2022
• Supplement Dates FDA Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2022
• 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: BOSTON: 0.018" V18 GUIDEWIRE.; MEDIKIT: 6F PARENT INTRODUCER SHEATH.