MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. SINGLE LUMEN EMBOLECTOMY CATHETER

Catalog Number E1601-26

Device Problem Deflation Problem (1149)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/16/2019

Event Type  Injury  

Manufacturer Narrative

We have received the complaint device for evaluation and we have confirmed the reported incident.The catheter was missing the balloon and the catheter tip.We observed excessive necking of the catheter lumen.The catheter was measured to 102 cm ( 28% extension ).As a result, the inflation lumen was occluded.During our follow-up investigation.We learned that the balloon inflated properly inside the patient's vessel and while attempting to remove the clot, the catheter was stuck and could not be removed.So, the surgeon deflated the balloon and removed the catheter from the patient's vessel with some resistance.However, he observed the catheter tip and the balloon was missing from the catheter shaft.This operated patient is known to have an ischemic arm due to trauma and a history of prior surgeries at this region.The operating surgeon confirmed that he was able to remove the balloon portion and he did not see any residual obstruction during angiogram.Patient has been discharged from the hospital.He tentatively thinks that the balloon could have been stuck on the sharp angled origin of a branch that was calcified.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.As part of our manufacturing process, a 100% balloon and winding inspection are performed on each of the manufactured product to ensure each catheter operates properly.Based on our device evaluation and follow-up investigation, it is likely that some anatomical feature ( calcification or stenosis in the lesion area ) along with procedural factors ( use of excessive force to remove the clot ) may have contributed to the balloon separation.Our ifu appropriately warns the users about the risks that could occur with the use of the embolectomy catheter including the risk of tip separation.The arterial embolectomy catheter is not recommended for the removal of fibrous, adherent or calcified material ( eg.Chronic clot, atherosclerotic plaque ).This catheter is not designed to withstand the additional pull force needed to remove these materials.

Event Description

During declotting, the balloon of the embolectomy catheter dislodged from the catheter shaft and was retained in the patient's blood vessel.Patient is known to have an ischemic arm due to trauma and a history of prior surgeries.Surgeon was able to remove the dislodged balloon and the catheter tip.Patient has been discharged from the hospital.

• Brand Name: SINGLE LUMEN 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 ; 7812212266
• MDR Report Key: 9506365
• MDR Text Key: 174334741
• Report Number: 1220948-2019-00171
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00840663100552
• UDI-Public: 00840663100552
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/19/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: E1601-26
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention