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

Model Number	123F6P
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluations are 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.Devices not returned.
Event or Problem Description
It was reported that, the packaging on these 2 swan-ganz catheters from the same lot number were 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.
Additional 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.The marks were part of the tray and were not condensation.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.The indentations did not penetrate the tray.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
• Common Device Name: 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: 14015231
• Report Number: 2015691-2022-04837
• Device Sequence Number: 17382827
• Product Code: DQO
• UDI-Device Identifier: 50690103000370
• UDI-Public: (01)50690103000370(17)230712(11)210712(10)63883560
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMEN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/12/2023
• Device Model Number: 123F6P
• Device Lot Number: 63883560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2022
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown