MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR FOGARTY ARTERIAL EMBOLECTOMY CATHETER; CATHETER, EMBOLECTOMY

Model Number 120602FP

Device Problem Contamination (1120)

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

Event Type  malfunction  

Event Description

It was reported that the border between the catheter and the balloon seemed to be swollen and thicker than before.The customer did not want to use the catheter for concern of the possibility of damaging blood vessels during insertion.There were no patient complications reported.An unknown material detached during evaluation and was sent to chemistry for further analysis.The sample spectrum is consistent with that of zein (protein based material).

Manufacturer Narrative

One 120602f catheter was received for evaluation without any attached components.There was blood visible on balloon and windings.The reported issue of the catheter being swollen was confirmed.The proximal windings appeared thicker than known good lab sample.Furthermore, the proximal side of proximal windings was discolored.The catheter tube was bent at distal side of the hub.There was no other visible damage or abnormality observed from windings, balloon, and catheter body.The balloon inflated with 0.2 cc air as recommended in the ifu.The balloon inflated clear and concentric and did not leak.The catheter was sent for outer diameter (od) measurement.The outer diameter at the brown location was measured to be 0.0445" which was within specification.A review of the manufacturing records indicated that the product met specifications upon release.An unknown material detached during evaluation and was sent to chemistry for further analysis.The sample spectrum is consistent with that of zein (protein based material).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 a part of the monthly review.

• Brand Name: FOGARTY ARTERIAL EMBOLECTOMY CATHETER
• Type of Device: CATHETER, EMBOLECTOMY
• 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: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 13691099
• MDR Text Key: 290145203
• Report Number: 2015691-2022-04310
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PREAMENDMEN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2022
• Device Model Number: 120602FP
• Device Catalogue Number: 120602FP
• Device Lot Number: 63325817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2022
• Initial Date FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2020
• 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