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

Model Number EL3380

Device Problems Material Puncture/Hole (1504); Material Rupture (1546); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/10/2022

Event Type  malfunction  

Event Description

Fogarty balloon.#1: balloon tip dislodged.#2: balloon has many holes.#3: balloon tip burst and foreign body retained in patient.Re-position the catheter after pulling out.Foreign body retained in patient, may require further local exploration and retrieval.

Manufacturer Narrative

This is a retrospective electronic medical device reporting, as a correction of deficiencies observed from usfda inspection (fei no.: (b)(4), inspection date: 11/6/2023-11/9/2023).Some information (especially the patient information) was not available as the event was occurred in 2022.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: 18919213
• MDR Text Key: 337857651
• Report Number: 3016261803-2024-00002
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K973477
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: EL3380
• Device Lot Number: H220400070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2022
• Initial Date FDA Received: 03/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention