MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP III 5 MM X 22 MM; CATHETER, THROMBUS RETRIEVER

Model Number ET309522

Device Problems Failure to Advance (2524); Material Twisted/Bent (2981)

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

Event Date 03/13/2023

Event Type  malfunction  

Event Description

The healthcare professional reported that during a thrombectomy procedure, a 5mm x 22mm embotrap iii revascularization device (et309522 / 22l202av) was attempted to be placed through a touhy borst (nordson medical) and a.025 catheter.It was reported that the embotrap iii device was advanced partially and it stopped.When the embotrap iii device was removed, there was a 90-degree bend between the stent and wire.On (b)(6) 2023, additional information was received.The information indicated that the thrombectomy procedure was targeting the right middle cerebral artery (mca).The microcatheter used was a.025¿ straight velocity® microcatheter (penumbra).It was not necessary to remove or replace the microcatheter.The damage at the pint of the kink was not noticeable.The embotrap iii device was stuck as it was advanced, but they were able to pull it back with ease.There was no obstruction noted on the microcatheter.The information indicated that a device from another company was used and it went through the microcatheter with ease.A continuous flush was maintained through the microcatheter.It was reported that at first the device was advanced easily but met resistance.It was then immediately removed.The complaint device was returned for evaluation and analysis.Based on the result of the product analysis completed on (b)(6) 2023, the reported issue meets usfda reporting criteria under 21 cfr 803 as a "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.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: the initial examination and examination under magnification of the returned embotrap device showed evidence of damage and deformation present on the returned device.The proximal struts were kinked and there was deformation of the proximal end of the device.The visual inspection also indicates that the returned embotrap device was correctly assembled and manufactured, with all adhesive bonds and joints complete and undamaged.The returned embotrap device was successfully passed through a 0.0195-inch inner diameter (id) tube, confirming that the profile conformed to the specification for compatibility with 0.021-inch microcatheters.Hence, the embotrap device is also compatible with 0.025¿ microcatheters.Device insertion and delivery assessments were performed using the returned embotrap device and a sample velocity 25 microcatheter.The returned embotrap device was successfully delivered to the distal tip of the sample velocity 25 microcatheter without issue.The complaint event was not confirmed using the returned embotrap device and a sample velocity 25 microcatheter.Device insertion and delivery assessments were also performed using a sample embotrap device and a sample velocity 25 microcatheter.These assessments demonstrated that failure to seat the insertion tool correctly can result in the proximal struts of the embotrap device moving distally to the proximal segment of the device in the velocity 25 microcatheter hub and subsequently causing kinking of the proximal struts of the embotrap device and deformation of the proximal end of the embotrap device.A review of the manufacturing documentation associated with this lot (22l202av) 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.Investigation conclusion: the returned embotrap device shows signs of damage or deformation.A visual examination of the microcatheter used during the complaint event was not possible as the microcatheter used during the complaint event was not returned for examination.Assessments carried out as part of this investigation demonstrated the returned device could successfully deliver through a sample velocity 25 microcatheter.However, with poor positioning (>15mm gap) similar damage and deformation to the returned unit, was replicated on a sample embotrap unit.In the absence of a physical investigation of the microcatheter used in the event reported, a probable cause of the complaint event is failing to maintain correct seating of the insertion tool either initially or through the rotating hemostasis valve (rhv) seal not being fully tightened thereby allowing some movement of the insertion tool in the rhv during device delivery.As demonstrated, attempting to deliver the embotrap device without fully seating the insertion tool can result in damage and deformation of the embotrap device.There is no indication that this complaint was a result of a defect or malfunction of the embotrap device.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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 III 5 MM X 22 MM
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 16827585
• MDR Text Key: 314532446
• Report Number: 3011370111-2023-00050
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704082866
• UDI-Public: 10886704082866
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ET309522
• Device Catalogue Number: ET309522
• Device Lot Number: 22L202AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2022
• 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
• Treatment: .025" STRAIGHT VELOCITY® MICROCATHETER (PENUMBRA).; TOUHY BORST (NORDSON MEDICAL).