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

Model Number 85910P

Device Problems Material Separation (1562); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2017

Event Type  malfunction  

Manufacturer Narrative

Internal reference: (b)(4).This case was reviewed and investigated according to the manufacturer's policy.Additional information obtained indicated the manufacturer's device was inspected during prep and found no damage.The device was used one time for a single pass.After the pass was made from sfa to distal lesion, an attempted recorded pullback was made and that is when resistance was felt.The device could not be removed easily/successfully over the wire.The catheter seemed to get hung up on the sheath at the wire exit port.When it would not advance back into the sheath past that point, they continued their attempt to remove it.Half of the catheter came out and the other half remained in the vessel, lodged on the sheath.When attempting to remove the rest of the system, the sheath came out without the remainder of the catheter.The remaining portion of the catheter was lodged at the skin/tissue line and after creating a larger access through the skin with kelly clamps they were able to remove the remainder of the catheter.All parts were accounted for, as assessed by physical fluoroscopic inspection by the physician.Additional lidocaine administration was necessary due to expanding the skin/tissue with kelly clamps at the end of the procedure.The patient was discharged as expected and was reported to be in "fine" condition.No tests/laboratory data was available.By report, no elevated labs and no other precluding events, no outstanding conditions prior to procedure.The implant or explant dates are not applicable to this device.The device was returned and evaluated in accordance with the manufacturer's policy.The guidewire was separated from the catheter.Both segments of the catheter device were inspected.The distal shaft of the catheter was torn off the proximal shaft 10 mm distal to the guidewire port, the portion of the distal shaft that remained was stretched and torn along the guidewire port, the corewire was curved and remained with the proximal end of the device, and several kinks and bends were present along the proximal shaft.The majority of the distal shaft was separated from the device and stuck on the guidewire returned with it.The guidewire was bent in on itself in a tight bunch.The distal shaft had been stretched approximately 90 mm to a total length of 330 mm.The distal shaft and inner member were torn and from 67 to 330 mm from the distal tip.The radiopaque markers were intact and remained in place 25, 35, and 45 mm from the distal tip.The weld legs were uneven in alignment and there was blood and air bubbles present within the proximal fillet.The probable cause of the reported failure would be damage in use by attempting to pullback the device over the bunched portion of the guidewire as evidenced by the intact radiopaque markers, and the tight bend on the guidewire.Strain, impact, and forces associated with use can affect the integrity of the device.The instructions for use (ifu) state: precautions: when inserting the guide wire both catheter and wire must be straight with no bends or kinks, or damage to inner lumen may occur.- do not advance the guide wire against significant resistance.If binding occurs between the catheter and the guide wire while inside the patient, carefully remove both the wire and catheter and do not use.If binding occurs outside of the patient, remove the catheter and do not use.- if resistance is encountered during pullback, remove the entire system (guide wire, ivus catheter, sheath/guide catheter) at the same time.The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.There were no nonconforming material reports or deviations noted that would contribute to the reported failure mode.This complaint will be monitored as part of complaint data analysis.

Event Description

It was reported the physician gained access on the right side using a.014 journey wire.They were able to advance the catheter over the wire, and over the bifurcation.They recorded the run going down [to the lesion] and had no difficulties.When recording the run back [pull back] they felt resistance and had trouble removing the catheter.The physician was unable to move back over the wire.When removing catheter and wire, upon reaching the sheath, the catheter would not advance.The physician was unable to re-enter the sheath for removal.The catheter and wire were removed as a system.The catheter broke into two pieces.The physician had difficulty retrieving the proximal portion out of the vessel, however all pieces were account for upon removal.Ivus was discontinued for the remainder of the case, but they were able to access the left side and completed the case by stenting.This event is being reported because additional intervention was required to remove the device.The vessel was described as: standard sfa lesion, 50%-70% occluded (speculated), no tortuosity.Other devices in use: terumo 6fx45cm sheath, boston scientific journey wire (260cm).

• Brand Name: VISIONS PV.014P RX DIGITAL IVUS CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): VOLCANO CORPORATION; 3721 valley centre dr ste 500; san diego CA 92130
• Manufacturer (Section G): VOLCARICA S.R.L.; coyol free zone&business park; b37; alajuela, costa rica ; CS
• Manufacturer Contact: tom brennan ; 3721 valley centre dr #500; san diego, CA 92130 ; 8587641320
• MDR Report Key: 6324462
• MDR Text Key: 67264470
• Report Number: 2939520-2017-00015
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 00845225002428
• UDI-Public: (01)00845225002428(17)181130
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: 85910P
• Device Catalogue Number: 400-0200.233
• Device Lot Number: 0242 50084571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 92