MAUDE Adverse Event Report: BIOPTIMAL INTERNATIONAL PTE. LTD. BIOPTIMAL INTERNATIONAL PTE. LTD.; EMBOLECTOMY CATHETER

Model Number EL3380

Device Problems Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 04/13/2021

Event Type  malfunction  

Event Description

Bypassthrombectomy; dr.(b)(6) informed that he used less than the allowed volume of fluid for inflation; resistance was felt; he meant a venous valve; the balloon was already defective when it was withdrawn; the piece of vein was discarded; so there is nothing left of the burst balloon in the patient.Patient status is ok (no injury).

Manufacturer Narrative

This is a retrospective electronic medical device reporting, as a correction of deficiencies observed from usfda inspection (fei no.: 3016261803, inspection date: 11/6/2023-11/9/2023).Some information (especially the patient information) was not available as the event was occurred in 2021.This is an initial and also a final retrospective report to fda, supplemental report is not available as the incomplete information was no longer accesible.

• Brand Name: BIOPTIMAL INTERNATIONAL PTE. LTD.
• Type of Device: EMBOLECTOMY CATHETER
• Manufacturer (Section D): BIOPTIMAL INTERNATIONAL PTE. LTD.; 36 jalan tukang; jurong west, sg-05 61926 6; SN 619266
• Manufacturer (Section G): BIOPTIMAL INTERNATIONAL PTE. LTD.; 36 jalan tukang; jurong west, sg-05 61926 6; SN 619266
• Manufacturer Contact: francisjoey eduave ; 36 jalan tukang; jurong west, sg-05 61926-6 ; SN 619266
• MDR Report Key: 18919208
• MDR Text Key: 337853217
• Report Number: 3016261803-2024-00001
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K973477
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/15/2024

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 Expiration Date: 10/31/2022
• Device Model Number: EL3380
• Device Lot Number: H191000209, H200900187
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/21/2021
• Initial Date FDA Received: 03/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/11/2019
• 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): Other