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

Model Number	12TLW405F35
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our product evaluation lab received one catheter from the reported model.Dry blood was visible inside the through lumen at the tip.The balloon was inflated with 1.7ml air and balloon inflated concentric and did not leak.The balloon was able to be deflated completely within 2 seconds.Then the balloon was inflated with 0.9ml of water.Flow restriction was found when inflating the balloon with water.The balloon could not be deflated completely after 15 seconds by pulling back on syringe plunger.Balloon deflation time was out of specification.The maximum deflation time from full capacity was 15 seconds.A cut-down was performed on the catheter body to locate the occlusion.The inflation lumen was found to be collapsed underneath proximal bushing of the balloon and created flow restriction.The balloon latex, bushings and windings were intact.The through lumen was patent without any leakage or occlusion.No visible damage was observed from catheter body or returned syringe.A device history record review was initiated to document whether the device met all specifications upon distribution.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.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.
Event or Problem Description
It was reported that a 12tlw405f35 fogarty catheter balloon could not deflate during a procedure.The customer made sure that the catheter was not in the locked position and the balloon would still not deflate.The catheter was removed from the patient by attaching a bigger syringe and negative pressure was drawn on the balloon to deflate it enough to get it out through the sheath.They confirmed no injury to the patient.
Additional Manufacturer Narrative
A supplemental mdr is being submitted due to the engineering evaluation findings.Sections g6, h2 and h6 - type of investigation findings, investigation findings and investigation conclusions have been updated.Engineering evaluation was completed.A product risk assessment was generated to address the balloon deflation issues.Additionally, a capa was initiated to perform actions regarding the balloon deflation issues and is currently in investigation phase.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
• Common Device Name: FOGARTY THRU-LUMEN 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: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 17232211
• Report Number: 2015691-2023-14268
• Device Sequence Number: 20598959
• Product Code: DXE
• UDI-Device Identifier: 00690103043488
• UDI-Public: (01)00690103043488(17)250621(11)230323(10)64924178
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K892410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2023

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: 06/21/2025
• Device Model Number: 12TLW405F35
• Device Catalogue Number: 12TLW405F35
• Device Lot Number: 64924178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2023
• 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: 06/15/2023
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2023
• 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