MAUDE Adverse Event Report: VOLCANO CORPORATION VERRATA PRESSURE GUIDE WIRE; WIRE, GUIDE, CATHETER

Model Number 10185

Device Problems Stretched (1601); Material Distortion (2977); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).This case was reviewed and investigated according to philips volcano policy.Additional information obtained indicated the wire stuck in the sub-intimal distal/apex lad.The pressure guide wire was removed using an over-the wire (otw) ptca balloon catheter.All portions of the device appeared to be accounted for upon removal.No damage was observed by either the scrub technical or physician.The procedure was completed by rewiring the distal lad lesion with an abbott all star 190cm wire for pci.Visual and microscopic inspections were performed on the returned device.It was observed that the distal coil was stretched to 313mm in length but was intact.The distal end of the core wire was twisted and broken.Approximately 21.5mm of the core wire extended past the sensor housing.The remaining 8mm of the core wire was still soldered to the dome.The entirety of the core wire appeared to be present.The core wire was broken at the distal tip and, as a result, the distal coil was significantly stretched.This damage likely occurred as a result of mechanical strain during the procedure while the user attempted to free the device from being stuck.Unfortunately, we were unable to conclusively determine through visual and microscopic inspection how the device initially became stuck.The instructions for use (ifu) warn, "never advance, torque or retract a pressure guide wire which meets significant resistance.The ifu also cautions," the volcano pressure guide wire should not be advanced if resistance is encountered.The wire should never be forcibly pushed into a vessel.Any time that resistance is encountered, the wire should be withdrawn under fluoroscopic guidance.In some instances, the wire may kink and must be removed." the manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.To date, no other complaints were reported for this same failure mode within this lot.We will continue to monitor these types of complaints.

Event Description

It was reported the device was used to do an ifr.They sent the wire down to the distal lad and the wire got stuck.The physician tried to pull the wire back, but the distal tip frayed and elongated.The physician used an over-the-wire (otw) balloon catheter and removed everything.Physician did not try to repeat the procedure and proceeded with a stent.There was no patient injury.Patient was discharged as expected; condition was noted as stable and pain free.All reasonably known patient information is included in this report.

• Brand Name: VERRATA PRESSURE GUIDE WIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore road; rancho cordova CA 95670
• 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: 5649379
• MDR Text Key: 44992440
• Report Number: 2939520-2016-00022
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131288
• 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: 04/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 10185
• Device Catalogue Number: 400-0300.16
• Device Lot Number: 0243 50057297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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 Age: 52 YR
• Patient Weight: 71