MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ TRUE SIZE MONITORING CATHETER DOUBLE LUMEN; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 123F6P

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2022

Event Type  malfunction  

Event Description

It was reported that prior to use, the packaging on this swan-ganz catheter was observed to have puncture-like holes and what looks like condensation marks.Images were provided by the customer.There was no patient injury reported.The customer shared that there were multiple devices that had the same issue.As a result of the issue found, the customer pulled their model 123f6p and 110f5 swan-ganz catheters and inspected them all for holes in the packaging.The issue was resolved by switching to a non-edwards brand pulmonary artery catheter.

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

Manufacturer Narrative

One 123f6 catheter, in sealed packaging, was returned for examination.The reported issue of "marks" was confirmed.As received, indentations and opaque marks around the indentations were observed on the outer surface of the plastic tray.Most indentations were 0.03" in diameter.The marks were round and varied in sizes.The images provided by the customer had similar marks as the received product.The report of "puncture holes" was not confirmed.There was no other visible defect or damage observed from the packaging.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.

• Brand Name: SWAN-GANZ TRUE SIZE MONITORING CATHETER DOUBLE LUMEN
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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 atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 14015260
• MDR Text Key: 288632737
• Report Number: 2015691-2022-04839
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 50690103000370
• UDI-Public: (01)50690103000370(17)231220(11)211220(10)64113604
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMEN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2023
• Device Model Number: 123F6P
• Device Lot Number: 64113604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2021
• 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