MAUDE Adverse Event Report: PHILIPS VOLCANO VISIONS PV .014P RX; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 014R

Device Problems Entrapment of Device (1212); Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/29/2021

Event Type  Injury  

Event Description

It was reported that during a therapeutic peripheral procedure, after the patient was treated with angiography and atherectomy, the manufacturer's catheter was used to image the popliteal artery.During removal, the catheter got stuck to the non-manufacturer¿s guidewire and broke off in the popliteal artery.The physician decided not to remove the separated portion and jailed by a stent, since a stent was going to be placed regardless.Angiography demonstrated excellent flow through the popliteal and tibioperoneal trunk with good posterior tibial artery runoff all the way to the foot.The proximal catheter, guidewire, and sheath were removed from the patient.The patient tolerated the procedure well and was discharged as expected.Additionally, the physician believed the cause was likely an access issue in the introducer sheath or an issue with the guidewire.This adverse event and product problem is being submitted because the distal portion of the manufacturer's catheter was retained in the patient, requiring additional intervention.

Manufacturer Narrative

This case was reviewed and investigated according to the manufacturer¿s policy.No information available.No information available.Not applicable for this device.Lot #, expiration date, serial #, udi #, and device manufacture date are unknown.Not applicable for this device.User facility #: mw5105011.Visions pv.014p rx catheter was discarded by the facility, thus no returned product investigation was performed.Per the ifu precautions, if resistance is encountered during pullback, remove the entire system (guide wire, ivus catheter, sheath/guide catheter) at the same time.The ifu warns there is potential critical harm to patient due to device separation.

• Brand Name: VISIONS PV .014P RX
• 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 par; b37; alajuela ; CS
• Manufacturer Contact: ayse yarimoglu ; 3721 valley centre drive; #500; san diego, CA 92130
• MDR Report Key: 13454375
• MDR Text Key: 289178993
• Report Number: 3008363989-2022-00006
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2022

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
• Device Operator: Health Professional
• Device Model Number: 014R
• Device Catalogue Number: 400-0200.297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 SCIENTIFIC: 0.018" GUIDEWIRE.; UNK MFG: 6F INTRODUCER SHEATH.
• Patient Outcome(s): Required Intervention