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

Catalog Number A4F03

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 04/12/2022

Event Type  Injury  

Event Description

During embolectomy, using a 3 fr balloon catheter, the balloon broke and there was a thin/long piece of metal that was stuck in the artery.He tried many times to retrieve it with a snare but was unable to.It ended up requiring an extra incision for the patient.

Manufacturer Narrative

We have received the complaint device for evaluation.We have confirmed the reported incident.We observed the spring tip has separated from the catheter lumen.The balloon was also found to be missing.Based on the evaluation of the returned unit, it is likely that the maximum pull force for the event unit was exceeded, which caused the balloon to rupture and the spring to separate from the catheter lumen.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.

• Brand Name: SYNTEL SILICONE EMBOLECTOMY CATHETER
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; lemaitre vascular, inc.; 63 second ave 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: 14380951
• MDR Text Key: 294674980
• Report Number: 1220948-2022-00039
• Device Sequence Number: 1
• Product Code: DXE
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/12/2022

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: A4F03
• Device Lot Number: SSE1122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2022
• Initial Date FDA Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2021
• 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