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

Model Number	C146F7
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.The udi number for this device is: (b)(4).
Additional Manufacturer Narrative
One c146f7 with monoject limited volume syringe was recieved for evaluation.Catheter body was received in three pieces with a black rod.Catheter was cut at 29cm and 30cm from catheter tip.The reported event of component coming off was unable to be confirmed.Per description of event, "the catheter was then removed and cut open, and the same type of wire material was removed." as received, catheter was cut at 29cm and 30cm from catheter tip and unknown black marker closed to the proximal port was also returned.The edges at the cuts appeared to match.The findings were aligned to customer photo.Per drawing 670674 rev.Al, rod-tantalum was used to plug proximal lumen at the lumen port.Adhesive material was visible on the rod.However, further evaluation regarding manufacturing non conformance will be conducted.A device history record review was completed and documented that device met all specifications upon distribution.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.
Additional Manufacturer Narrative
The product evaluation could not confirm since the catheter was returned cut at 29cm and 30cm.As per the image and the evaluation provided, the piece of metal is the "rod tantalum" (in: 400896004) that is part of the manufacturing process and is inserted inside the proximal injectate port.Since the device was returned cut, the allegation was unable to be confirmed.However, adhesive is applied to the plug (rod tantalum - in: 400896004), and then it is inserted from the wetted side towards the distal side of the proximal slot.The plug must be flush with the edge of the slot.There are multiple procedures in place to ensure that the plug is snug and not protruding the space.Then a second coat of adhesive is applied over the plug.The location is verified that the slot area does not have excess adhesive and that it does not cover the proximal part of the tube; and finally, it is verified that the "tantalum rods" in the npvc product remain in position.Based on the procedures, if the unit had a defect as rod tantalum detached or any cut, it would have been capture during these inspection processes.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
• Common Device Name: 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: 12921381
• Report Number: 2015691-2021-06637
• Device Sequence Number: 12007772
• Product Code: DYG
• UDI-Device Identifier: 00690103153132
• UDI-Public: (01)00690103153132(17)231015(11)211015(10)64007718
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K001063
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2022

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 Expiration Date: 10/15/2023
• Device Model Number: C146F7
• Device Catalogue Number: C146F7
• Device Lot Number: 64007718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2021
• Supplement Date Received by Manufacturer: 12/08/2021; 01/27/2022
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 12/22/2021; 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown