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

Model Number I300F85

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2018

Event Type  malfunction  

Manufacturer Narrative

Our product evaluation laboratory received two images for review.Both images showed the identical sample of a hemostasis introducer with a dilator inserted in the valve housing.An unknown, brownish material was taped to the introducer.The composition of the unknown substance was not able to be determined from the image.A device history record review was completed and documented that the device met all specifications upon distribution.The customer report of "foreign matter" was confirmed on evaluation.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.With an indwelling introducer, it is common for the clinician to check for air or particulates while priming the line for use.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.In this event, this issue was noted before use and the device was not used with a 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.(b)(4).

Event Description

It was reported that prior to use of an introflex introducer, foreign matter was noticed inside lumen.There was no patient injury.The device was discarded, but images were provided.

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: 7926717
• MDR Text Key: 122635880
• Report Number: 2015691-2018-04003
• 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: 09/14/2018

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 Expiration Date: 04/29/2020
• Device Model Number: I300F85
• Device Lot Number: 61371713
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/14/2018
• Initial Date FDA Received: 10/02/2018
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 01/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR