MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR CATHETER/INTRODUCER COMBO SYSTEM; CATHETER, FLOW DIRECTED

Model Number C146F7

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

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

Event Date 11/12/2021

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 when it is available.

Event Description

It was reported that there is some type of a metal piece on this catheter close to the the proximal port that is coming off.This short piece of metal became dislodged and was moving under fluoro.The catheter was then removed and cut open, and the same type of wire material was removed.There is no patient injury reported.

Manufacturer Narrative

The device was not returned for evaluation.There were two instances of the same malfunction, but only one device was available for return.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.The lot number was not provided thus a device history record could not reviewed.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 a part of the monthly review.

• Brand Name: CATHETER/INTRODUCER COMBO SYSTEM
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 12921387
• MDR Text Key: 284971702
• Report Number: 2015691-2021-06636
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: C146F7
• Device Catalogue Number: C146F7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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