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

Model Number C146F7

Device Problems Inflation Problem (1310); Material Puncture/Hole (1504); Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); No Known Impact Or Consequence To Patient (2692)

Event Date 09/18/2017

Event Type  malfunction  

Manufacturer Narrative

Without the return of the product, it is not possible to determine if damages or defects exist on the product, nor can any manufacturing nonconformance, failure mode, root cause, or potential contributing factors be identified.No actions will be taken at this time.A device history record review has been initiated and a supplemental report with the findings will be submit upon completion.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 insert or use the catheter, to consider the potential benefits in relation to the possible complications.The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications are well described in the literature.The ifu issues a caution that establishes: ¿this product contains natural rubber latex which may cause allergic reactions.¿ additionally, the other complications section of the ifu establishes that: ¿¿allergic reactions to latex have been reported.Physicians should identify latex sensitive patients and be prepared to treat allergic reactions promptly¿.A ¿symbol legend¿ displays a triangle symbol with ¿latex¿ written inside it and the meaning of the symbol described as: ¿contains the presence of natural rubber latex.¿ it is unknown whether user or procedural factors contributed to the stated event.Udi #: (b)(4).

Event Description

Per a maude database search, maude report # (b)(4) dated sept-2017 was discovered.It was reported that the balloon on two non-latex swan-ganz catheters had holes.The doctor tested the first balloon (lot 60891023) in a flush bowl prior to insertion into the patient.The balloon had tested appropriately, held water and deflated appropriately.The doctor then inserted the balloon through a 12fr sheath and advanced the catheter but was then unable to inflate the balloon.He removed the swan-ganz catheter from the patient and re-tested the balloon in a flush bowl, where it was observed that the balloon had a hole.The doctor called for another latex-free swan-ganz catheter with a different lot number (lot 60921831).Again, the balloon worked prior to insertion and again, was discovered to have a hole in it after insertion and removal through the 12fr sheath.The doctor then pre-treated the patient for latex allergy and called for a latex swan-ganz catheter.The balloon on the latex catheter inflated without any problems.There was no mention in the report of any patient injury or consequence.There is also no mention as to what type of "pre-treatment" was provided or if the patient had any previous known latex allergy reactions, etc.No patient demographics are provided on the report.It states the device was available for evaluation; however, there is no identifying hospital or contact information listed on the report to enable follow-up by the manufacturer.

Manufacturer Narrative

A device history record review was completed and documented that the device met all specifications upon distribution.

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: 8713191
• MDR Text Key: 151029541
• Report Number: 2015691-2019-02228
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K001063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2019
• Device Model Number: C146F7
• Device Catalogue Number: C146F7
• Device Lot Number: 60891023
• 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
• Patient Outcome(s): Other