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

Catalog Number	1601-38
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Alteration In Body Temperature (2682)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the device for evaluation and we have confirmed the reported incident.The balloon as well as the distal and the proximal ligatures were missing from the balloon.No necking was observed on the shaft of the catheter.Glue was still observed to be present on the proximal groove that binds the ligature.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.At this time, we could not conclusively determine the root cause of the issue.It is possible that the tension or the amount of glue 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 currently have a corrective and preventive action ( capa ) open to address this issue.After the issue was detected, surgeon made an incision and another embolectomy catheter was used to check and ensure that the balloon was not left in the patient's vessel.An ultrasound of the upper arm and chest x-ray was performed later to ensure there were no after effects of postoperative deep-vein thrombosis.The patient did not experience shortness of breath and appeared well.The physician thinks that the balloon ended up in the yankauer suction tip.According to the hospital, although the fistula stopped a few days later, the patient has not suffered from any further illness.
Event or Problem Description
During removal of thrombus from the fistula at the left arm, lemaitre embolectomy catheter was inserted and the balloon was inflated with approximately 0.2 ml of heparinized saline.While pulling the thrombus out of the vessel, the balloon snagged at the elbow.So, the physician deflated the balloon slightly and then continued to withdraw the catheter.When the catheter was removed completely from the patient's vessel, he found out that the balloon was missing from 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: 7874858
• Report Number: 1220948-2017-00076
• Device Sequence Number: 1927914
• Product Code: DXE
• UDI-Device Identifier: 00840663100477
• UDI-Public: 00840663100477
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/13/2018

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: Health Professional
• Device Expiration Date: 03/28/2024
• Device Catalogue Number: 1601-38
• Device Lot Number: SLC4559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 09/13/2018
• 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