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	05/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a visions catheter was used in a peripheral therapeutic procedure via left arm radial artery access.The catheter was loaded over a 0.018 guidewire via sheath and was able to advance, but could not reach due to the distance from the access site to the target vessel.During removal, resistance was noted due to the guide wire wrapped around the catheter; therefore, the catheter and guide wire were removed together.Upon removal it was observed that the catheter tip was missing.Fluoroscopic images confirmed the tip was located inside the patients left distal radial artery.A snare was deployed, along with a surgical cutdown approach to retrieve the missing tip successfully.This adverse event and product problem is being submitted because the visions catheter tip separated inside the patient, requiring additional intervention for removal.
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacturer¿s policy.Block c: not applicable for this device.Blocks d6 & d7: not applicable for this device.Block g2: user facility report# (b)(4).Blocks h3 & h6: the visions catheter was not returned for evaluation, thus no returned product investigation was performed.Blocks h7 & h9: 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.
Additional Manufacturer Narrative
Blocks d9 & h3: visions pv catheter was returned for evaluation.Block h3: the visions pv catheter was returned without the distal portion (includes distal tip, distal fillet, scanner body, and a portion of the expanded single lumen (esl)).The returned proximal portion (includes a portion of the esl, catheter shaft, luer connector, and cable connector) measured at approx.137 cm from the distal end to the luer connector.Visual inspection found a slightly stretched esl and exposed microcables with sharp edges observed.It is likely that the distal portion measured approx.1.7 cm which is within the overall catheter working length (135-139 cm) when including the returned proximal portion of 137 cm.Block h6: the probable cause of the catheter separation 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
• 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: danielle bullock ; 3721 valley centre drive #500; san diego, CA 92130 ; 619633-4179
• MDR Report Key: 17321639
• Report Number: 3008363989-2023-00026
• Device Sequence Number: 6893719
• Product Code: OBJ
• UDI-Device Identifier: 00184360000037
• UDI-Public: (01)00184360000037(11)221220(17)241220(10)0302787597
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2023

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: 12/20/2024
• Device Model Number: 86700
• Device Catalogue Number: 400-0200.285
• Device Lot Number: 0302787597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2022
• 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: TERUMO: 6F SLENDER INTRODUCER SHEATH; TERUMO: GLIDEWIRE ADVANTAGE 0.018, GUIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White