MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER; CATHETER, EMBOLECTOMY

Model Number 12TLW805F35

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 06/02/2022

Event Type  malfunction  

Event Description

It was reported that the balloon of a fogarty catheter could not maintain its inflation during use in the patient, even though there was no problem with the balloon at the inflation test before use.The device was replaced, and the problem was solved.There were no patient complications reported.

Manufacturer Narrative

The reported event of balloon could not maintain its inflation was not confirmed.However, visual examination found three cracks at catheter tip.Crack 1 located outer surface of tip was less than 0.5 mm long, crack 2 and 3 could not be measured because they were inside of the lumen.It was unable to determine if edges of cracks matched up.The balloon was inflated with 1.7 ml air and 0.9 ml water as recommended in japanese product ifu.The balloon inflated clear and concentric and remained inflated for 5 min.Without leakage.No visible damages were observed from the balloon and windings.The through lumen was found to be patent and did not leak.Further evaluation regarding supplier related quality issues is under investigation.A device history record review was completed and concluded a non conformance report was found.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.

Manufacturer Narrative

An engineering evaluation was initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Based on the investigation, the most probable root cause for the high incidence of crack defects in the catheter tip area is associated to the units handling when inserting and removing the mandrel during the manufacturing process.In addition, an opportunity was identified to align the instructions of the tip inspection in the different procedures used in the operations where the tip area is inspected.A capa was generated to address the issue.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 15029306
• MDR Text Key: 295988472
• Report Number: 2015691-2022-06801
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00690103043532
• UDI-Public: (01)00690103043532(17)230917(11)210618(10)63843857
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K892410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2022

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 Expiration Date: 09/17/2023
• Device Model Number: 12TLW805F35
• Device Catalogue Number: 12TLW805F35
• Device Lot Number: 63843857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 07/15/2022
• Supplement Dates Manufacturer Received: 08/08/2022
• Supplement Dates FDA Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2021
• 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