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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. LEMAITRE OVER-THE-WIRE EMBOLECTOMY CATHETER

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LEMAITRE VASCULAR, INC. LEMAITRE OVER-THE-WIRE EMBOLECTOMY CATHETER Back to Search Results
Catalog Number 1651-48
Device Problem Deflation Problem (1149)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/20/2020
Event Type  malfunction  
Manufacturer Narrative
We have received the complaint device for evaluation.We have confirmed the reported incident.The proximal ligature has slipped above the skive hole.As a result, the balloon could not deflate.We did not observe any necking of the catheter lumen and the catheter length was measured to be within specification.We observed multiple kinks in the catheter lumen at 20-30 cm and 60-70 cm mark.When the catheter lumen was cut above the 70 cm mark and we attempted to flush the inflation lumen, we were able to flush the lumen but we experienced resistance when pushing the plunger of the syringe.We then cut the lumen below the 20 cm mark and attempted to flush the inflation lumen.We were able to flush the lumen easily.Based on our evaluation, it is possible that the multiple kinks that we observed in this catheter might have contributed to the balloon deflation issue during the procedure and led to ligature slippage as the surgeon was removing the catheter from the patient's vessel.It is also possible that the ligature was not sufficiently tied to the catheter lumen resulting in the ligature slippage.We have requested the user to provide us with additional information relating to this incident.We have not yet received a response back form the customer.Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident.As part of our manufacturing process, a 100% balloon and winding inspection are performed on each of the manufactured product.The arterial embolectomy catheter is not recommended for the removal of fibrous, adherent, or calcified material (e.G.Chronic clot, atherosclerotic plaque).This catheter is not designed to withstand the additional pull force needed to remove these materials.There was no harm to the patient as the result of this incident.Surgeon used another lemaitre over-the-wire embolectomy catheter to complete the procedure.
 
Event Description
During thrombectomy, surgeon was unable to deflate the balloon of the lemaitre over-the-wire embolectomy catheter.The operation was successfully completed using another lemaitre over-the-wire embolectomy catheter.There was no harm to the patient as the result of this malfunction.
 
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Brand Name
LEMAITRE OVER-THE-WIRE EMBOLECTOMY CATHETER
Type of Device
EMBOLECTOMY CATHETER
Manufacturer (Section D)
LEMAITRE VASCULAR, INC.
63 second ave
burlington MA 01803
Manufacturer (Section G)
LEMAITRE VASCULAR, INC.
63 second ave
burlington MA 01803
Manufacturer Contact
pragya thikey
63 second ave
burlington, MA 01803
7212212266
MDR Report Key11028003
MDR Text Key231798504
Report Number1220948-2020-00121
Device Sequence Number1
Product Code DXE
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K022145
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 12/16/2020
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 Catalogue Number1651-48
Device Lot NumberOTW4306
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/20/2020
Initial Date FDA Received12/17/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/02/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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