MAUDE Adverse Event Report: INFRAREDX, INC. TVC INSIGHT CATHETER HYDROPHILIC; ULTRASONIC PULSED ECHO IMAGING SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER

Model Number TVC-C195-22

Device Problems Material Separation (1562); Physical Resistance (2578); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/11/2017

Event Type  malfunction  

Manufacturer Narrative

User facility believes that use of excessive force likely led to catheter malfunction.Incident was not reported by the physician or user facility.Incident discovered by chance by company employee during training.

Event Description

Percutaneous coronary intervention of lcx and lad.Catheter was delivered to lcx, but no imaging performed.Resistance was felt when pulling catheter from lcx.Catheter may have been kinked.Second wire may have been present in lad.Catheter and guidewire pulled together into the guide catheter.Additional resistance felt when catheter and guidewire reached guide catheter.More force applied to retrieve catheter and guidewire.Distal opaque marker section of distal tip separated from catheter.All of catheter, guidewire, and guide catheter recovered from patient.No injury to patient.No treatment of patient due to imaging catheter malfunction.Angiogram unremarkable.

Manufacturer Narrative

Patient angiograms were forwarded to and examined by infraredx.No unusual findings.Device history record (dhr) for catheter was reviewed.No unusual findings.Root cause of complaint (b)(4) determined to be user error.Potential complications of delivering and removing a catheter during a procedure were reviewed with user.No complaints from patient and no complications observed.No treatment administered as a result of problem using catheter.No subsequent hospitalization of patient required.No further investigation required.(b)(4).

• Brand Name: TVC INSIGHT CATHETER HYDROPHILIC
• Type of Device: ULTRASONIC PULSED ECHO IMAGING SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER
• Manufacturer (Section D): INFRAREDX, INC.; 34 third ave; burlington MA 01803 4414
• Manufacturer (Section G): INFRAREDX, INC.; 34 third ave; burlington MA 01803 4414
• Manufacturer Contact: stephen sum ; 34 third ave; burlington, MA 01803-4414 ; 7813459651
• MDR Report Key: 6614554
• MDR Text Key: 76946752
• Report Number: 3004722468-2017-00001
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130719
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2018
• Device Model Number: TVC-C195-22
• Device Lot Number: F83007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2016
• 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: 69 YR