MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR VOLUMEVIEW; PROBE, THERMODILUTION

Model Number VLV8R520

Device Problems Fracture (1260); Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2019

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.A device history record review has been initiated to ensure that the device met all specifications upon distribution.A supplemental report will be submit upon completion.

Event Description

It was reported that during use of a volumeview set, the femoral catheter fractured in the thermistor connector.Per additional follow-up, it was clarified that the catheter broke during manipulation of the connector when tightening.A new catheter was placed through a new insertion site.There was no allegation of patient injury.

Manufacturer Narrative

Our product evaluation laboratory received one volume view sensor kit and one single dpt kit with one manifold and one thermistor connector.The thermistor extension tube and leadwires were cut from the connector housing.No leadwires were noticed inside the connector housing.The remaining catheter was not returned.The cut appeared to be even and smooth.The findings were aligned to the customer photo in which it could be seen the thermistor connector was cut from the thermistor extension tube and the leadwires were exposed from the extension tube.The volumeview and dpt sensor iv lines were found cut distal from each sensor at approximately 150cm and 120cm, respectively.The cuts appeared to be even and smooth.No other visible damage was noticed from the returned unit.A device history record review was completed and documented that the device met all specifications upon distribution.The customer report of "catheter fractured" was confirmed on evaluation.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications.The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications is well described in the literature.In this case, the patient required a new stick to insert a new device.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: VOLUMEVIEW
• Type of Device: PROBE, THERMODILUTION
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8958094
• MDR Text Key: 196420749
• Report Number: 2015691-2019-03288
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• PMA/PMN Number: K100739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VLV8R520
• Device Catalogue Number: VLV8R520
• Device Lot Number: 61525341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 68