MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING SET; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number PX3X3

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2022

Event Type  malfunction  

Event Description

As reported, during one procedure, immediately after opening the packages of these two pressure monitoring sets (medwatch #17545 and #17546), the tyvek pouch was found torn.There was no allegation of patient injury.Patient demographics unable to be obtained.The devices were available for evaluation.

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.

Manufacturer Narrative

One pressure monitoring set was received by our product evaluation laboratory for a full examination.The report of tyvek pouch damaged was confirmed.Tyvek cover was found cut in 8.8 cm in length.The cut appeared straight and smooth.The seal around tyvek pouch appeared intact.No other abnormality was noticed from the returned kit.In general, packaging non-conformances that results in a breach of the sterile package (i.E.Pinhole, tear or seal issue) have the potential to result in a serious infection.In this case, there is evidence that packaging was damaged in an extent that made it easily possible for edwards quality control personnel or the user of the device to detect the non-conformance.The packaging is damaged in a way, that it is always detected prior to use and could not go undetected.As such, this event is no longer considered reportable and a corrected supplemental report is being submitted.

• Brand Name: PRESSURE MONITORING SET
• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 14884316
• MDR Text Key: 298976756
• Report Number: 2015691-2022-06510
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2022

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 Model Number: PX3X3
• Device Catalogue Number: PX3X3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/24/2022
• Initial Date FDA Received: 07/01/2022
• Supplement Dates Manufacturer Received: 07/19/2022
• Supplement Dates FDA Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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