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

Model Number	86700
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Device: not applicable for this device.The visions pv.018 catheter was not returned for evaluation, thus no returned product investigation was performed.Do not apply to this submission.
Event or Problem Description
It was reported that during a therapeutic peripheral procedure, the visions pv.018 catheter distal tip separated while it was being retracted from the external left common iliac artery.The separated tip was removed with a snare and the procedure was completed with a non-manufacturer balloon-expandable stent system.The patient tolerated the procedure well with no patient injury reported.The patient was transferred to pacu for monitoring.This adverse event and product problem is being submitted due to the tip separation requiring intervention (snare).
Additional Manufacturer Narrative
Block a4: patient weight available.Block a5: patient ethnicity and race available.Block d10: guide wire brand name available.Block g3: additional information was received on 18 july 2022; however, it was inadvertently missed in the supplemental 1 mdr submitted on 09 august 2022.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.
Additional Manufacturer Narrative
Blocks b6 & b7: patient information received.Block h3: the visions pv.018 was returned without the distal portion of the device.The distal portion includes the distal tip, distal fillet, and scanner body.The overall device measures 142 cm, which confirms 3.3 cm was not returned.The portion of the device that was returned measures at 138.7 cm.Visual inspection found a hole on the expanded single lumen measuring approximately 0.04 square mm.Block h6: the probable cause of the observed failure is damage during use/handling.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
• Common Device Name: 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: 14709396
• Report Number: 3008363989-2022-00034
• Device Sequence Number: 2264976
• Product Code: OBJ
• UDI-Device Identifier: 00184360000037
• UDI-Public: (01)00184360000037(11)220208(17)240208(10)0302510509
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K150442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/08/2024
• Device Model Number: 86700
• Device Catalogue Number: 86700
• Device Lot Number: 0302510509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 07/14/2022; 07/18/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 08/09/2022; 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6F INTRODUCER SHEATH, MFG UNK; ABBOTT COMMAND ES GUIDE WIRE; UNK MFG AND SIZE: GUIDE WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White