MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. SYNTEL SILICONE THROMBECTOMY CATHETER

Catalog Number A45XX PART NUMBERS

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2024

Event Type  malfunction  

Event Description

It has been reported that during the use of the syntel silicone thrombectomy catheter, the guide tip (not the balloon or catheter) can become damaged and result in tip detaching.The risk of this issue is that the distal tip of the catheter separates while in use in the patient and requires additional medical intervention to prevent injury.Four complaints have been reported for this issue including a total of seven devices of the same catalog # a4545 (syntel thrombectomy catheter, 4f, 50cm) from three different lots: sst1030, sst1032, and sst1036.Complaints from one customer, puerto rico vascular access center, included six of the seven devices from the 3 lots above; and lifeline vascular / southwest access center (illinois) complaint included the seventh device from lot sst1032.No injuries have occurred as a result of this issue.No additional complaints for this issue have been received since august 2023, confirming the remote occurrence.However, if the issue occurs it may cause temporarily or medically reversible health consequences, where the probability of serious adverse health consequences is remote; therefore, we have determined that the product is violative and we conclude that regulatory action is required in the form of a class ii recall.Please note: prior emdr submissions have been made for each of the reported failures (see h10, related report numbers section for report numbers).

Manufacturer Narrative

As part of our analysis of data review during a management review meeting a trend was identified for these complaints, and it was determined to issue capa 2023-028.During our initial failure investigation, a potential cause was identified for high variation in the process due to its manual processing nature and unclear manufacturing instructions.Further testing (e.G., doe) determined that some devices failed to meet our pull test specification.No additional complaints for this issue have been received since august 2023, confirming the remote occurrence.However, if the issue occurs it may cause temporarily or medically reversible health consequences, where the probability of serious adverse health consequences is remote; therefore, we have determined that the product is violative and we conclude that regulatory action is required in the form of a class ii recall.

• Brand Name: SYNTEL SILICONE THROMBECTOMY CATHETER
• Type of Device: THROMBECTOMY 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: jeffrey oddy ; 63 second ave; burlington, MA 01803 ; 7814251682
• MDR Report Key: 19059191
• MDR Text Key: 339586824
• Report Number: 1220948-2024-00100
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• PMA/PMN Number: K910372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: A45XX PART NUMBERS
• Device Lot Number: SSTXXXX LOT NUMBERS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/08/2024
• 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