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

Catalog Number ET007533

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.The name, phone and email address of the initial reporter are not available / reported.Conclusion: the healthcare professional reported that during the thrombectomy procedure, after making one pass with the clot not retrieved well as intended; it was somewhat retrieved, the 5mm x 33mm embotrap ii revascularization device ((b)(4)) was being cleaned using heparinized saline in preparation for another pass attempt, when the outer cage became kinked / bent.It was reported that the device was not rubbed gently from the proximal to distal end to remove any residual thrombus material as instructed in the instructions for use (ifu).It was reported that excessive force had been applied to the device.The physician cannot specifically remember where the clot was trapped on the device nor can he specifically remember the size and consistency of the clot.The reported event resulted in less than a minute delay; the device was discarded right after it was damaged.The procedure was successfully completed with the replacement device.The ifu for device cleaning has been delivered to physician again.There was no report of any patient adverse event or complication.Based on complaint information, the device was not available to be returned for analysis.A review of the manufacturing documentation associated with this lot (19k196av) top and sub assembly presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.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 information and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.The most likely cause to the reported issue is device handling; it was documented that the device was not rubbed gently from the proximal to the distal end during the cleaning process with heparinized saline in preparation for another pass attempt.It was during the cleaning process that the outer cage became kinked / bent.The ifu has instructions for how to handle the device during cleaning; the physician has been provided with another copy of the ifu for device cleaning.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 during the thrombectomy procedure, after making one pass with the clot not retrieved well as intended; it was somewhat retrieved, the 5mm x 33mm embotrap ii revascularization device ((b)(4)) was being cleaned using heparinized saline in preparation for another pass attempt, when the outer cage became kinked/bent.It was reported that the device was not rubbed gently from the proximal to distal end to remove any residual thrombus material as instructed in the instructions for use (ifu).It was reported that excessive force had been applied to the device.The physician cannot specifically remember where the clot was trapped on the device nor can he specifically remember the size and consistency of the clot.The reported event resulted in less than a minute delay; the device was discarded right after it was damaged.The procedure was successfully completed with the replacement device.The ifu for device cleaning has been delivered to physician again.There was no report of any patient adverse event, or complication.

• 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 drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10838556
• MDR Text Key: 216688972
• Report Number: 3011370111-2020-00086
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K173452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/02/2020

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 Expiration Date: 09/16/2022
• Device Catalogue Number: ET007533
• Device Lot Number: 19K196AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 11/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2019
• 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