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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
Model Number e1651-38
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/15/2020
Event Type  Injury  
Manufacturer Narrative
We have not received the complaint device for evaluation since the device is currently at the hospital.However, we have observed the reported incident in the picture provided to us.The investigation is ongoing.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.Further, we have not received any other complaints of a similar nature for devices from this lot.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.
 
Event Description
Tip broke off into the patient.No injury to patient.
 
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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 Key11029420
MDR Text Key222100707
Report Number1220948-2020-00122
Device Sequence Number1
Product Code DXE
UDI-Device Identifier00840663100774
UDI-Public00840663100774
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K022145
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 12/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Numbere1651-38
Device Catalogue NumberE1651-38
Device Lot NumberOTW4328
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/22/2020
Initial Date FDA Received12/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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
Patient Outcome(s) Required Intervention;
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