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

Model Number 12TLW803F

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/19/2021

Event Type  malfunction  

Manufacturer Narrative

One fogarty embolectomy catheter with attached stylet wire and blue sheath was returned for evaluation.As received, the stylet wire located between 26.5 cm distal from tip and 68.0 cm proximal from tip.It was able to remove the stylet wire from the thru-lumen but resistance was felt when the stylet wire was removed.Closer examination confirmed that there was unknown viscous material on the inner wall of the thru-lumen at the catheter tip.The unknown material was removed and sent to chemistry for analysis.No visible damage or abnormality to the stylet wire was observed.The thru-lumen was patent without any leakage.The balloon inflated clear, concentric and remained inflated for 5 minutes without leakage.Balloon inflation test was performed using lab syringe with 0.4 cc air and 0.15 cc water as recommended in the product ifu.Visual examination was performed under microscope at 20x magnification and with the unaided eyes.A device history record review was completed and documented that device met all specifications upon distribution.Customer report of stylet removal issue was confirmed.A supplemental report will be sent with the chemistry investigation results.

Event Description

It was reported that the stylet of the fogarty thru-lumen embolectomy catheter could not be removed prior to use.The catheter could not be used for the procedure.Patient demographic information requested but not available.There were no patient complications reported.

Manufacturer Narrative

The ir spectrum of the unknown material (contamination in catheter tip) is consistent with that of siloxane.Per further engineering evaluation the residual unknown can be traced back to silicone grease used in the manufacturing process.

• Brand Name: FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER
• Type of Device: FOGARTY CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 11718490
• MDR Text Key: 248846293
• Report Number: 2015691-2021-02638
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• PMA/PMN Number: K892410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/17/2021

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: 12/29/2021
• Device Model Number: 12TLW803F
• Device Catalogue Number: 12TLW803F
• Device Lot Number: 62625935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/02/2021
• Initial Date FDA Received: 04/23/2021
• Supplement Dates Manufacturer Received: 04/23/2021
• Supplement Dates FDA Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1