MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER; CATHETER, OXIMETER, FIBEROPTIC

Model Number 777F8

Device Problems Break (1069); Material Separation (1562); Component Missing (2306); Detachment of Device or Device Component (2907)

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

Event Date 08/27/2018

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 during coronary artery bypass graft on a (b)(6) male, the tip of the swan-ganz catheter broke off.The balloon inflation and deflation had been tested prior to insertion through the 9f introducer sheath.After insertion, the swan could not be wedged and was removed.Upon removal it was noted that the balloon was missing.No interventions were performed.The patient tolerated the procedure well and was taken to sicu.Per follow-up, the patient was reported as stable with no noted injury at one day post-op.

Manufacturer Narrative

Upon follow-up with the customer for return of the product, it was discovered that the customer had used the labeling information off of the biohazard kit that was sent to them from a third party vendor (for the return of this complaint¿s product), and shipped a non-edwards, carefusion brand cable back to the aforementioned third party vendor.Unfortunately, the third party vendor is only equipped to send out biohazard kits on behalf of edwards, and is not in the business of receiving products of any sort.Arrangements were made to ship the cable back to the customer, as there is no alleged involvement or allegation against it in this complaint.The customer is unaware of where the suspect catheter associated with this complaint was shipped and both biokit tracking numbers indicate that kits were delivered to the customer, but no return shipping activity has been activated.The product is currently assumed to be lost in transit and will not be returned for evaluation.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor can a root cause or any potential contributing factors be identified.No actions will be taken at this time.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 is well described in the literature.It is standard practice to check balloon integrity by inflating it to the recommended volume in order to detect any asymmetry or leakage condition before use of the catheter.When there is separation of the balloon or fragments from the pulmonary artery catheter, the retained fragment will embolize to the lungs.Due to the large surface area of the pulmonary vasculature, this is generally well tolerated, but can lead to complications such as infection or small infarction.Pulmonary complications may result from improper inflation technique.To avoid damage to the pulmonary artery and possible balloon rupture, the balloon should not be inflated above the recommended volume.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.

Manufacturer Narrative

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

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 7879001
• MDR Text Key: 120704956
• Report Number: 2015691-2018-03818
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K040287
• 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: 08/27/2018

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: 02/06/2020
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 61263483
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/27/2018
• Initial Date FDA Received: 09/14/2018
• Supplement Dates Manufacturer Received: 09/26/2018; 07/23/2020
• Supplement Dates FDA Received: 10/12/2018; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 78