MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP II 5X33 REVASC. DEV.; CATHETER, THROMBUS RETRIEVER

Model Number ET009533

Device Problem Difficult to Remove (1528)

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

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Date of event: the date of the event is not known.The expiration date of the device is not known as the device lot number is not available / not reported.The device manufacture date is not known as the device lot number is not available / not reported.[conclusion]: the healthcare professional reported that at a product round table discussion on 16-nov-2021, it was reported that the 5mm x 33mm embotrap ii revascularization device (et009533 / lot# unknown) encountered difficulty during the attempt to withdrawal it through the vessel.It was not known if continuous flush was maintained.There was no report of any patient adverse event or complication.The complaint product is not available for return.Based on complaint information, the device is not available to be returned for analysis.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the limited information available and without the product available for analysis, the reported customer complaint could not be confirmed.The lot number of the device is not known, therefore review of the device history record was not performed.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction, thrombus / clot size / vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

The healthcare professional reported that at a product round table discussion on 16-nov-2021, it was reported that the 5mm x 33mm embotrap ii revascularization device (et009533 / lot# unknown) encountered difficulty during the attempt to withdrawal it through the vessel.It was not known if continuous flush was maintained.There was no report of any patient adverse event or complication.The complaint product is not available for return.

Manufacturer Narrative

Manufacturer¿s ref.No: pc-(b)(4).The purpose of this mdr submission is to include the additional event information received on 06-dec-2021.[additional information]: the healthcare professional reported that at a product round table discussion on 16-nov-2021, it was reported that the 5mm x 33mm embotrap ii revascularization device (et009533 / lot# unknown) encountered difficulty during the attempt to withdrawal it through the vessel.It was not known if continuous flush was maintained.There was no report of any patient adverse event or complication.The complaint product is not available for return.On 06-dec-2021, additional information was received.The information indicated that the procedure date of this event is not clear.The cause of the reported withdrawal difficulty is not known nor suspected.It was confirmed that there was no adverse outcome to the patient as a result of the reported issue.The reported issue did not result in a clinically significant delay in the procedure.E.1: the initial reporter phone: (b)(6).The initial reporter email address was not available / reported.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: EMBOTRAP II 5X33 REVASC. DEV.
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): NEURAVI LTD.; block 3; ballybritt business park; galway H91 K 5YD; EI H91 K5YD
• Manufacturer (Section G): ADVANT MEDICAL; parkmore business park west; galway H91 P V0V; EI H91 PV0V
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-868
• MDR Report Key: 12936810
• MDR Text Key: 286651943
• Report Number: 3011370111-2021-00150
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704081326
• UDI-Public: 10886704081326
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

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 Operator: Health Professional
• Device Model Number: ET009533
• Device Catalogue Number: ET009533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 12/06/2021
• Supplement Dates Manufacturer Received: 12/06/2021
• Supplement Dates FDA Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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