MAUDE Adverse Event Report: OPSENS OPTOWIRE DEUX; PRESSURE GUIDEWIRE

Model Number F1014

Device Problems Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/12/2018

Event Type  Injury  

Manufacturer Narrative

Based on the received narrative and the investigation under microscope of the failed device, the fractured corewire revealed no trace of fatigue neither any mechanical flaw.It is therefore believed that the core wire has been twisted by the physician until it torn itself following an entrapment in a small branch.(b)(4).

Event Description

As narrative received by opsens: rca#1, moderate occlusion.When the ow was addressed to distal end of #4, the ow was trapped into small branch.So the doctor tried to withdraw the ow to re-insert into #4, but the ow stuck.To release the stuck ow, the doctor tried following procedure but not effective; inserted micro catheter finecross (terumo) to overlap stuck, dilated with small diameter balloon at #4, inserted two gw(for pci) to trap ow.Finally the stuck ow had been fractured.The doctor performed pci to #1 which was scheduled from the first pre-dilatation, stenting, post-dilatation.From oct diagnosis, the ow fragment was lain at #1 distal ~ #2 proximal area, it was not supported by the stent which was lain at #1.(optical coherence tomography) since the patient already had stents at #2 and #3, the doctor gave up to place additional stent to press fragment to vessel wall, considering the risk of double stenting.Though the fragment is remained in the coronary, the patient was stable.For now, no additional procedure to retrieve the ow fragment is planned.Update received by opsens: on 18th, zeon's team visited oita medical center to have an interview with dr.Arikawa.Following is the doctor's comment: the patient already left the hospital, without any health damage which may brought by remained fracture.The patient will be followed with dual anti-platelet therapy, the follow-up angiography is planned after 8 months.The doctor provided us the angio.The doctor said that the distal tip of the ow had stuck into small branch.Then the doctor observed into the vessel by otc, noticed that the proximal part of the fragment was floating in the vessel.The doctor inserted two guidewire (for pci) to try to catch the fragment, but he could not deliver two wires to circled area.The balloon and micro catheter are also tried, but not effective because to insert them across the stuck fragment was impossible.The doctor does not regard this ow as defective products.On 26th, zeon's sales personnel visited oita medical center again to follow the doctor.· the doctor said that the patients have not been getting worse.Zeon's inspection of the defective device: the proximal fragment of ow was returned for inspection.The distal tip of returned ow seems significantly twisted and pulled, which resulted into fracture.The length of core wire of returned ow was 30mm.From the feature of the end of returned fragment, the core wire has not been corroded; seemed to be extraordinary rotated and pulled.

• Brand Name: OPTOWIRE DEUX
• Type of Device: PRESSURE GUIDEWIRE
• Manufacturer (Section D): OPSENS; 750, boul. parc technologique; quebec city, G1P 4 S3; CA G1P 4S3
• Manufacturer (Section G): OPSENS; 750, boul. parc technologique; quebec city, G1P 4 S3; CA G1P 4S3
• Manufacturer Contact: marc dugas ; 750, boul. parc technologique; quebec city, quebec G1P 4-S3 ; CA G1P 4S3
• MDR Report Key: 8686536
• MDR Text Key: 147578258
• Report Number: 3008061490-2018-00003
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K152991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/16/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: F1014
• Device Catalogue Number: F1014
• Device Lot Number: OW-0623D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2018
• Initial Date FDA Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2018
• 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): Other; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 74