MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR PRESEP CENTRAL VENOUS OXIMETRY SET; PRESEP CATHETER

Model Number X3820SJD

Device Problems Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problems Congenital Defect/Deformity (1782); No Code Available (3191)

Event Date 11/05/2018

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation; it was discarded at the hospital.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.No actions will be taken at this time.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.There are instructions in the ifu for proper securing of the catheter.It is unknown if user or procedural factors played a role in the stated event.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 by the anesthesiologist, that during re-mustard + tricuspid valve replacement (tvr) surgery, a swan ganz catheter came out from the patient body.The catheter was used on a (b)(6) male patient with transposition of the great arteries (tga).The catheter was fixed with a box clamp, suture loop and suture wing.Intra-aortic balloon pump (iabp) and percutaneous cardiopulmonary support (pcps) were introduced.It is reported that the catecholamine could not be injected to the patient properly due to the event, resulting in introduction of intra-aortic balloon pump (iabp) and pcps.The device was discarded at the hospital.

Manufacturer Narrative

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

• Brand Name: PRESEP CENTRAL VENOUS OXIMETRY SET
• Type of Device: PRESEP CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8161651
• MDR Text Key: 130315062
• Report Number: 2015691-2018-05253
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K053609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X3820SJD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/13/2018
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Weight: 56