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

Model Number I300F85

Device Problems Material Separation (1562); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2019

Event Type  malfunction  

Manufacturer Narrative

Our product evaluation laboratory received one hemostasis valve introducer on its original opened tray (lot 61532849) with one dilator, one guidewire, two 5cc syringes, one contamination shield, one cap, one sharp receptacle, and four gauze pads.Examination of the hemostasis-type introducer found the wiper gasket to be missing from the valve housing.Resistance was felt when inserting and removing the dilator from the introducer.Further examination found that the wiper gasket was stuck in the sheath body at approximately 9cm from the distal tip.The dilator was hard to insert when the wiper gasket occluded the lumen.The wiper gasket was found bent and torn when it was removed from the sheath.When the wiper gasket was removed, the dilator was able to pass freely through the entire length of the introducer without issues.The duckbill valve was undamaged.A device history record review was completed and documented that the device met all specifications upon distribution.The customer report of "difficulty to place" was confirmed on evaluation.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to perform the procedure, to consider the potential benefits in relation to the possible complications.In this case, the wiper gasket was missing from the valve housing of the introducer and was inside the introducer sheath, which has the potential to embolize into the patient.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 there was difficulty placing the sheath with the introducer.A new introducer was not used.No additional information was able to be obtained.There was no patient injury.

Manufacturer Narrative

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

• Brand Name: PERCUTANEOUS SHEATH INTRODUCER SET
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 9110901
• MDR Text Key: 196555407
• Report Number: 2015691-2019-03549
• Device Sequence Number: 1
• Product Code: DQY
• 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
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Model Number: I300F85
• Device Lot Number: 61532849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 68