MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS; CATHETER, FLOW DIRECTED

Model Number C146F7

Device Problems Material Separation (1562); Component Missing (2306)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.A device history record review was completed and documented that the device met all specifications upon distribution.Udi # (b)(4).

Event Description

It was reported that when a model c146f7 catheter was removed after the procedure through a 7 fr sheath, it was immediately noted that the balloon was missing from the tip of the catheter.The table and sheath were extensively searched without finding the balloon.There was no allegation of patient injury.Patient demographics were requested and not provided.

Manufacturer Narrative

Upon further follow-up with the customer, it was determined that this reported event was a duplicate of a complaint already documented under mdr 2015691-2019-04674.

Manufacturer Narrative

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

• Brand Name: SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 9507375
• MDR Text Key: 188678216
• Report Number: 2015691-2019-04833
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2021
• Device Model Number: C146F7
• Device Catalogue Number: C146F7
• Device Lot Number: 62155394
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1