MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCERS; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number PX2X2

Device Problems No Display/Image (1183); Device Contamination with Chemical or Other Material (2944)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/30/2019

Event Type  malfunction  

Manufacturer Narrative

One double dpt kit was returned for examination.The reported event of "no waveform displayed" was not confirmed.No error message was observed on a pressure monitor.Both dpts zeroed and sensed pressure accurately on a pressure monitor.Electrical testing showed that both input and output impedances of both the blue and yellow dpt sensors respectively were within specifications.Zero-offset also met specification.However, unknown white particulates were found in the blue pressure tubing.The particulate was approximately 1 cm in size at approximately 10 and 15 cm proximal from distal pressure tubing connector.The particulates did not remain attached to the tubing surface and flushed out.Chemistry results of the particulates that were found inside of the pressure tubing indicated that the ir spectrum of unknown white material showed similar absorption characteristics when comparing to sebacic acid like material.(sebacic acid can be used in plasticizer and lubricants).An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint, including if sebacic material from the chemistry findings is associated with any component of the manufacturing process.A supplemental report will be sent with the investigation results.A review of the manufacturing records indicated that the product met specifications upon release.It is common clinical practice to inspect all products before usage.Additionally, these products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised to consider the potential benefits in relation to the possible complications.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.

Event Description

It was reported that during use the disposable pressure transducer did not display a waveform.There was no allegation of patient injury.The product was available for evaluation.

Manufacturer Narrative

Investigation found that the potential root cause for this nonconformance could be a supplier related material.The supplier uses sebacic acid as part of their manufacturing process of the tubing.A supplier notification was made to the manufacturer about this finding.

Manufacturer Narrative

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

• Brand Name: PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCERS
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• MDR Report Key: 9386459
• MDR Text Key: 189001340
• Report Number: 2015691-2019-04445
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• PMA/PMN Number: K925638
• 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: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2020
• Device Model Number: PX2X2
• Device Catalogue Number: PX2X2
• Device Lot Number: 61281046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 01/16/2020; 07/23/2020
• Supplement Dates FDA Received: 01/16/2020; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1