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

Model Number PX260

Device Problems Contamination /Decontamination Problem (2895); 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 02/12/2020

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.

Event Description

It was reported that during use in patient of this disposable pressure transducer (dpt), there was a foreign object found in the tubing of the product.There was no allegation of patient injury.The device was available for evaluation.Patient demographics are unavailable.

Manufacturer Narrative

The ir spectrum of both unknown dark material and clear tubing showed similar absorption characteristics when comparing to pvc like material.Investigation found that the potential root cause for this nonconformance could be a supplier related material. a supplier notification was made to tekni-plex the manufacturer about this finding. in addition, personnel acknowledgement was conducted at the manufacturing site to prevent recurrence of this type of complaint.

Manufacturer Narrative

One single dpt kit was returned for examination.The reported event of ¿foreign object found in the tubing of the product¿ was confirmed.An unknown dark particulate, about 1mm in length, was found attached to the inner wall of the distal pressure tubing at 6 cm from the female connector.The kit was flushed continuously for 5 minutes.The unknown material was flushed out from the kit during flushing and captured on filter paper.A review of the manufacturing records indicated that the product met specifications upon release.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.A supplemental report will be forthcoming with the chemistry results once received.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.It this event, no patient complications were reported.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

Reference capa-20-00141.

• Brand Name: PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
• 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: 9825234
• MDR Text Key: 194509173
• Report Number: 2015691-2020-10932
• 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,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2021
• Device Model Number: PX260
• Device Catalogue Number: PX260
• Device Lot Number: 62710034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1