MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR PERCUTANEOUS SHEATH INTRODUCER SET; CATHETER, FLOW DIRECTED

Model Number I300F85

Device Problems Fluid/Blood Leak (1250); Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2020

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 with patient of this introducer, blood leaked from the one-way valve when the medical staff punctured the patient's right internal jugular vein.Blood leakage observed was minimal.The problem was solved by replacing the sheath tube immediately in a new position by removing everything and starting the procedure from the beginning.There was no allegation of patient injury.The product was available for evaluation.Patient demographics were unable to be obtained.

Manufacturer Narrative

Although the report was submitted on time.The d10 section was not completed.

Manufacturer Narrative

One hemostasis introducer was returned for examination.The reported event of leakage was confirmed.A leak test was performed.Leakage was noticed in the sheath body at approximately 10.5cm from the distal tip.Leakage occurred from two slits of 0.01".No other visible abnormality was observed on the returned introducer.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.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the introducer, to consider the potential benefits in relation to the possible complications.The techniques for insertion and the occurrence of complications is well described in the literature.In this case, the patient required a new stick and the procedure was re-started.It is unknown if user or procedural factors may have contributed to this 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.

Manufacturer Narrative

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

• Brand Name: PERCUTANEOUS SHEATH INTRODUCER SET
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR
• MDR Report Key: 10365345
• MDR Text Key: 202714785
• Report Number: 2015691-2020-12929
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K831729
• 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: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2021
• Device Model Number: I300F85
• Device Lot Number: 62333283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1