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

Catalog Number	1601-48
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received one out of two reported complaint devices for evaluation.Please note that we have also submitted mdr manufacturer report number 1220948-2017-00064 for the same incident since the incident involved two units from two different lot number.We have confirmed the reported incident with the one returned device.We found that most of the proximal ligature had slipped from its intended position and had covered the inflation holes.As a result, the balloon could not deflate.Also, the distal ligature had slipped from its position and was no longer binding to the shaft although it was binding properly with the balloon.This suggest that the tension applied during winding of the threads to the lumen of the catheter was not strong enough to prevent the ligature from slipping from its position.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 issue.All qc tests passed their requirements.Further, we have not received any other complaints of similar nature for devices from this lot.We have not received any further information about the incident from the doctor.It is also possible that the tortuous anatomy of the patient, calcified plaque if present in the patient's vessel and excessive tension on the device during the procedure could also lead to this failure.We currently have a corrective and preventive action (capa) opened to investigate the root cause of this issue.The corrective action includes review of our manufacturing processes, materials and handling of the device.We have also made our manufacturing team aware of this issue.At this time, we are inconclusive about the root cause of this defect.We perform 100% inspection on each device to ensure that the ligature properly binds to the shaft and an adequate amount of glue is present in the ligature.
Event or Problem Description
Balloon could not be deflated.

• 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: 7010926
• Report Number: 1220948-2017-00063
• Device Sequence Number: 1144751
• Product Code: DXE
• UDI-Device Identifier: 00840663100484
• UDI-Public: 00840663100484
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 11/07/2017

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 Expiration Date: 11/28/2022
• Device Catalogue Number: 1601-48
• Device Lot Number: SLC4101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2017
• 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