MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ BIPOLAR PACING CATHETER (FOR INSERTION VIA SUPERIOR VENA CAVA); CATHETER, FLOW DIRECTED

Model Number D97120F5

Device Problem Off-Label Use (1494)

Patient Problem Extravasation (1842)

Event Date 02/25/2022

Event Type  Injury  

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

Event Description

It was reported via medwatch (b)(4), during use of swanganz catheter, sg model d97120f5, an extravasation injury occurred to the patients right upper arm.It was reported that a sg catheter was placed in the cath lab with a brand terumo glidesheath slender 6 french size introducer via the right brachial insertion site.The medications, levophed and vasopressin infused via the introducer side port.The customer reported this was only 11 inches long and when in the brachial vein, this was less than a midline catheter and was not considered a central line and the catheter was more consistent with a peripheral iv.In the critical care unit, three days later, the bedside registered nurse, rn switched the medications infusing from the side port to the proximal blue port of the sg, so that medication delivery would be central.The rn later discontinued the swan and obtained a peripherally inserted central catheter, picc.At the time of removal, it was noted that the patient has sustained an extravasation injury.Treatment included wound care cleansed daily with bacitracin to wound edges and adaptic applied, securing with kerlix and medipore tape.The patient was on palliative care for chronic severe end stage right heart failure and expired (b)(6) 2022.The patients death was not reported to be linked to the suspect device and reported event.Per the customer report, the root cause of event was determined to be a knowledge gap for the introducers location.The lot number was unknown, however, a udi number was provided and able to be associated to lot number 64056567.The customer reported suspect device was discarded upon removal.Per additional follow up, reporter acknowledged there was user error and education was performed on site.Knowledge gap for introducer location is not a central catheter and vesicant meds infusing for longer lengths of time resulted in extravasation injury.

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.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.An engineering evaluation has been initiated to assess for any manufacturing related processes which could be correlated to the complaint.

• Brand Name: SWAN-GANZ BIPOLAR PACING CATHETER (FOR INSERTION VIA SUPERIOR VENA CAVA)
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: jessica attalah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 14675755
• MDR Text Key: 294910660
• Report Number: 2015691-2022-06127
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00690103150421
• UDI-Public: (01)00690103150421(17)231116(11)211116(10)64056567
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K822723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2023
• Device Model Number: D97120F5
• Device Catalogue Number: D97120F5
• Device Lot Number: 64056567
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 28 KG