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

Catalog Number ET007533

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

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

Event Date 07/17/2023

Event Type  malfunction  

Event Description

As reported by the field, during a mechanical thrombectomy, an embotrap ii 5x33 revascularization device, became impeded in distal end of the unspecified microcatheter (mc) and could not pass through.The physician retracted the stent and observed that the distal tip of delivery wire was kinked/bent.A new stent was switched to complete the surgery.The microcatheter was not replaced.There was no patient injury report.

Manufacturer Narrative

Product complaint #: (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section e1.Initial reporter phone: (b)(6).Section h3 - the device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint # (b)(4).Section b5: additional information received indicated that the mc was used was a prowler select plus (606s255x, 30894115).There was no damage to the mc.The insertion tool was securely placed in the hub of the microcatheter prior to attempting to advance the embotrap.The rhv was tightened to hold the insertion tool in position during advancement of the device.The device was flushed without difficulty.There was no resistance required for the removal of the microcatheter and there was no subsequent loss of cerebral target position.No other devices passed through the microcatheter after this.Only one pass was made to attempt to retrieve the clot.There were no procedural delays due to the event.Complaint conclusion: as reported by the field, during a mechanical thrombectomy, an embotrap ii 5x33 revascularization device, became impeded in the distal end of the unspecified microcatheter (mc) and could not pass through.The physician retracted the stent and observed that the distal tip of delivery wire was kinked/bent.A new stent was switched to complete the surgery.The microcatheter was not replaced.There was no patient injury reported.Additional information received indicated that the mc was used was a prowler select plus (606s255x, 30894115).There was no damage to the mc.The insertion tool was securely placed in the hub of the microcatheter prior to attempting to advance the embotrap.The rhv was tightened to hold the insertion tool in position during advancement of the device.The device was flushed without difficulty.There was no resistance required for the removal of the microcatheter and there was no subsequent loss of cerebral target position.No other devices passed through the microcatheter after this.Only one pass was made to attempt to retrieve the clot.There were no procedural delays due to the event.The device was discarded; therefore, no further investigation can be performed.No capa or escalation activities are required at this time.A device history review (dhr) associated with lot 22f069av presented no issues during the manufacturing or inspection process that can be related to the reported complaint.With the information available and without the product available for analysis, the reported customer complaints could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.Per the instructions for use (ifu), insert the distal end of the insertion tool through the rhv of the microcatheter and wait until fluid is seen exiting the proximal end of the insertion tool, confirming that the device is flushed.Advance the insertion tool until it is fully seated in the hub of the microcatheter.Fully tighten the rhv to hold the insertion tool securely in position.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint #
=
> (b)(4).Updated sections on this medwatch: b4, g3, g6, h2, h3, h6 and h10.The initial inspection and examination under magnification of the returned embotrap device showed evidence of damage and deformation present on the distal coil.No other damage was evident on the returned device.The visual inspection also confirmed that the returned embotrap device was correctly assembled and manufactured, with all adhesive bonds and joint complete and undamaged.The returned embotrap device was successfully passed through a 0.0195¿ tube, confirming that the profile conforms to the specification for compatibility with 0.021¿ microcatheters.A device insertion and delivery assessment was performed using the returned embotrap device and a sample prowler select plus microcatheter.The returned embotrap was successfully inserted and delivered to the distal tip of the sample prowler select plus microcatheter, confirming that embotrap ii is compatible with the prowler select plus microcatheter.An attempt to recreate the failure to deliver was performed with a sample embotrap device and a sample prowler select plus microcatheter.The microcatheter was clamped in the distal area to simulate a kink or blockage (20mm from the tip) and the embotrap was tracked in it and repeatedly pushed against the blockage.Deformation of the distal coil was observed, similar to the returned unit, however additional damage to the distal portion of the outer cage was also observed which was not consistent with the returned complaint unit.Conclusion: it was reported that during the procedure the stent was impeded in the distal end of the microcatheter (prowler select plus), and ¿could not pass through¿.The physician retracted the stent and observed that the distal tip was kinked/bent.The returned embotrap device shows signs of damage and deformation on the distal coil, however, functional testing on the returned unit demonstrated that the device could be successfully inserted and delivered through a sample prowler select plus microcatheter.On attempt to recreate the event, a sample embotrap was inserted into a sample prowler select plus microcatheter while the distal section of the latter was clamped to simulate a blockage.Repeated pushing against the blockage resulted in deformation of the distal coil, similar to what observed on the returned devices although not to the same extent.The investigation suggests that the deformation of the embotrap is not likely the cause of the impediment in the microcatheter experienced by the physician, but might be the result of advancement of the embotap against a obstruction/kink/collapse of the microcatheter.However, the prowler select plus used in the procedure was not returned, thus examination to determine possible/contributing cause was not possible.This complaint is confirmed because there is visible damage to the distal tip of the returned unit, however the root cause of the damage or the failure to deliver could not be determined.There is no indication that this complaint was a result of a defect or malfunction of the embotrap device.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17417168
• MDR Text Key: 319975350
• Report Number: 3011370111-2023-00098
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K173452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ET007533
• Device Lot Number: 22F069AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT PLUS 150/5CM.; UNSPECIFIED MICROCATHETER.