MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR NON-BALLOON DUAL LUMEN OXIMETRY CATHETER; CATHETER, OXIMETER, FIBEROPTIC

Model Number 015F4

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2018

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.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.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.

Event Description

It was reported that during post-operative use of an oximetry catheter for a perimembranous interventricular communication in a (b)(6) female infant, blood leakage of ¿a few ml¿ occurred through the blue oximetry connector.The customer immediately withdrew the catheter, but stated it caused the ¿inability to monitor an important parameter¿ after surgery, though the specific parameter the customer was referring to was not specified.There was no injury or clinical consequence to the infant.

Manufacturer Narrative

Our product evaluation laboratory received one oximetry catheter.As received, blood was observed in the optic connector.The catheter body had two punctures holes located approximately 9.75cm proximal of the distal tip.Cut down was performed on the catheter tip to remove the optic fiber in the catheter body.A leak test was performed on the lumens.The catheter body appeared pushed in at the 0.01" mark along the puncture hole and pushed out at the 0.02" mark along the puncture hole.The punctures both entered through the optic lumen.The customer report of ¿blood leakage through the blue oximetry connector" was confirmed on evaluation.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.In this case, blood leakage occurred in a pediatric patient, who would have a lower threshold for brief interruptions in therapy or minor amounts of bleeding than an adult patient.This results in a higher potential for an injury to occur.It is unknown whether user or procedural factors contributed to the stated event.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: NON-BALLOON DUAL LUMEN OXIMETRY 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: 7449101
• MDR Text Key: 106152288
• Report Number: 2015691-2018-01507
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K901736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 015F4
• Device Catalogue Number: 015F4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Date Manufacturer Received: 05/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 3 MO
• Patient Weight: 4