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

Catalog Number	1601-44
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	10/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the device for evaluation.We have confirmed the reported incident.We observed that the proximal ligature was unwound and the distal ligature along with the balloon was missing.We observed extreme necking of the extrusion lumen at multiple locations indicating that the catheter was pulled with excessive force during the procedure.According to the surgeon, he could not inflate or deflate the balloon during the procedure nor could he pull or push the catheter ( 4 fr)after encountering the strictured region inside the blood vessel.After removing the catheter from the patient's blood vessel with excess force, he observed that the balloon had detached from the shaft.So, he flushed the lumen of the 6 fr shaft to check whether the detached balloon was contained within the sheath.However, he could not find the balloon.He then used a new unit of single lumen catheter to complete the procedure successfully.According to the surgeon, there was no impact on the patient's health as a result of this incident.Device was tested prior to the use and was found to be operational.We have conducted a lot history review and did not find any issues noted in the manufacturing or packaging process that could be related to this incident.All qc tests passed their requirements.All of the (b)(4) units manufactured in lot# slc4040 and (b)(4) out of (b)(4) units manufactured in lot# slc3925 has been sold.Moreover, we have not received any other complaints of similar nature for devices from these lots.It is likely the patient's constricted vessel along with the surgeon technique contributed to this incident.Our ifu clearly warns the user about the complications including balloon rupture that could occur during the procedure if exposed to calcified plaque.We do perform a periodic pull test on these devices to ensure that the ligatures are strong enough and are properly binding to the shaft.All of the units that were built around the timeframe when there units were built had passed the pull test.We have also opened a corrective action to investigate this issue.Slc3925: manufacturing date: 05/10/2016 expiration date: 04/28/2022.Slc4040: manufacturing date: 10/05/2016 expiration date: 09/28/2022.
Event or Problem Description
During thrombectomy for a dialysis patient, single lumen catheter was inserted into the patient's blood vessel.After the catheter reached its intended location, the balloon was inflated and pulled to remove the thrombi.While pulling the catheter, it encountered a strictured segment inside the blood vessel.When he tried to pull the catheter, he felt a resistance while doing so.He could not pull or push the catheter any further.When he tried to deflate the balloon, he could not do so either.So, he pulled the catheter with excessive force and was able to remove the catheter from the patient's vessel.However, he observed the balloon ( 1 cm in length ) was missing in the shaft of the catheter.

• Brand Name: SINGLE LUMEN EMBOLECTOMY CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 7010922
• Report Number: 1220948-2017-00062
• Device Sequence Number: 977932
• Product Code: DXE
• UDI-Device Identifier: 00840663100484
• UDI-Public: 00840663100484
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K992368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/06/2017

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
• Operator of Device: Physician
• Device Catalogue Number: 1601-44
• Device Lot Number: SLC3925 OR SLC4040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention