MAUDE Adverse Event Report: BIOSENSORS INTERNATIONAL PTE LTD THERMODILUTION CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number DTD1704HX5

Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2017

Event Type  malfunction  

Manufacturer Narrative

An internal complaint ((b)(4)) was received indicating that a thermodilution catheter (lot h161200084) malfunctioned during use, causing a 30-minute delay in the procedure.A sample was not available for return.The complaint investigator reviewed the work order for possible discrepancies that may have contributed to the reported incident.None were identified.The catheter is supplied to deroyal by (b)(4).Therefore, a supplier corrective action request (scar) was issued to (b)(4).As of the date of this report, a scar response has not been received.The 2014-2016 scar and supplier notification letter logs were reviewed for similar complaints, and similar complaints were identified.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.

Event Description

A right heart catherization procedure was delayed 30 minutes due to a failure of the thermodilution catheter.The 0.025 wire would not come out the very tip of the catheter.This occurred with three thermodilution catheters.

Manufacturer Narrative

Root cause: a supplier corrective action request (scar) issued to the manufacturer, biomedical sales international, was returned indicating that the device history record was reviewed and no abnormality was observed.This batch of production passed the inspection specification test.An actual root cause could not be determined because the defective sample was not returned for investigation.Corrective action: in its scar response, the manufacturer stated a corrective action had not been taken.All devices are 100 percent tested and inspected before shipment.Investigation summary: an internal complaint (call (b)(4)) was received indicating that a thermodilution catheter (lot h161200084) malfunctioned during use, causing a 30-minute delay in the procedure.A sample was not available for return.The complaint investigator reviewed the work order for possible discrepancies that may have contributed to the reported incident.None were identified.The catheter is supplied to deroyal by biomedical sales international.Therefore, a supplier corrective action request (scar) was issued to biomedical sales international and a response was received.The 2014-2016 scar and supplier notification letter logs were reviewed for similar complaints, and similar complaints were identified.Preventive action: in its scar response, the manufacturer stated a preventive action has not been taken due to the root cause determination.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

A right heart catherization procedure was delayed 30 minutes due to a failure of the thermodilution catheter.The 0.025 wire would not come out the very tip of the catheter.This occurred with three thermodilution catheters.

• Brand Name: THERMODILUTION CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BIOSENSORS INTERNATIONAL PTE LTD; 36 jalan takang; singapore south west, 61926 6; SN 619266
• MDR Report Key: 6993999
• MDR Text Key: 91333865
• Report Number: 1060680-2017-00019
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K911710
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DTD1704HX5
• Device Lot Number: H161200084
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1