MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 132CM EMBOVAC 71 ASP. CATHETER; EMBOVAC ASPIRATION CATHETER

Catalog Number IC71132CA

Device Problems Stretched (1601); Difficult to Advance (2920); Physical Resistance/Sticking (4012)

Patient Problems Intracranial Hemorrhage (1891); Perforation of Vessels (2135)

Event Date 10/27/2021

Event Type  Injury  

Event Description

It was reported by a healthcare professional (hcp) that during a mechanical thrombectomy of a left internal carotid artery (ica) occlusion (10mm clot), the physician attempted a second pass with a 132cm embovac 71 aspiration catheter (ic71132ca/30490109) after an unsuccessful first pass, but the microcatheter (size/brand not specified) would not advance to the proximal end of the clot.The physician used five microwires to guide the embovac without success.Therefore, the embovac was retrieved.During the retrieval, the embovac catheter completely collapsed on itself and stretched approximately 10-15cm proximal to the distal tip.The catheter lost its form.There was no device separation.The embovac was replaced with a different catheter to complete the procedure.Additional information received indicated that the device had been advanced or withdrawn against ¿some resistance¿ (pending clarification).The event resulted in bleeding; the hcp refused to elaborate.The surgery was delayed 40-60 minutes due to the event; it was not reported whether the physician felt the prolongation was clinically significant.Direct aspiration first pass technique (adapt) was performed (adapt); no snaking.Excessive force had not been applied to the device.The device was reportedly used and prepped as per the instructions for use (ifu).There was an adequate flush maintained through the devices.

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter phone: (b)(6).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.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr 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).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: it was reported by a healthcare professional (hcp) that during a mechanical thrombectomy of a left internal carotid artery (ica) occlusion (10mm clot), the physician attempted a second pass with a 132cm embovac 71 aspiration catheter (ic71132ca/30490109) after an unsuccessful first pass, but the microcatheter (size/brand not specified) would not advance to the proximal end of the clot.The physician used five microwires to guide the embovac without success.Therefore, the embovac was retrieved.During the retrieval, the embovac catheter completely collapsed on itself and stretched approximately 10-15cm proximal to the distal tip.The catheter lost its form.There was no device separation.The embovac was replaced with a different catheter to complete the procedure.Additional information received indicated that the device had been advanced or withdrawn against ¿some resistance¿.The event resulted in bleeding; the hcp refused to elaborate.The surgery was delayed 40-60 minutes due to the event; it was not reported whether the physician felt the prolongation was clinically significant.Direct aspiration first pass technique (adapt) was performed (adapt); no snaking.Excessive force had not been applied to the device.The device was reportedly used and prepped as per the instructions for use (ifu).There was an adequate flush maintained through the devices.No additional information is available.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation (mre) was performed for the finished device 30490109 number, and no non-conformances related to the malfunction were identified.Hemorrhage secondary to vessel injury is a known potential adverse event that may be associated with the use of the embovac in the intracranial arteries and is listed in the ifu as such.With the information provided, it is not possible to determine the root cause of the event.However, there are clinical and procedural factors including vessel characteristics, clot burden/characteristics, anatomical challenges, device selection, device interaction, operator technique, and mechanical manipulation of devices within the artery that may have contributed to the reported bleed.The type and severity of the bleed is unknown (i.E., parenchymal vs subarachnoid) and the relationship of the embovac to the reported event cannot be excluded.Difficulty tracking a catheter through the vasculature is a known procedural occurrence.The consequences of tracking difficulty occurring during clinical use of the device are usually addressed by modification in technique or substitution with another device.Tracking difficulty is most commonly related to the patient anatomy, operator technique, and appropriate device selection.Catheter unraveling/stretching and compression during clinical use is a known and common occurrence occurring during angiography and is typically related to anatomy, technique, skill, and vessel tortuosity.The instructions for use cautions users to inspect for kinks and bends, or other signs of damage prior to and during use.Any product with damage is not to be used.If the operator encounters damage during use, they are clinically trained to immediately discontinue manipulations and remove the product.Therefore, the potential for patient injury/death occurring as a result of kinking or bend type damage is remote.Interference or friction between devices is a known occurrence.Removal and exchange of devices is common routine practice in endovascular procedures.If resistance is encountered, the system being inserted should be withdrawn as a unit to prevent injury.This is a common practice during procedures and is recommended in product ifu¿s.The file will be re-reviewed if additional information is received at a later date.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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: 132CM EMBOVAC 71 ASP. CATHETER
• Type of Device: EMBOVAC ASPIRATION CATHETER
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC (MIRAMAR); 3260 executive way; miramar FL 33024
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12970316
• MDR Text Key: 287837058
• Report Number: 3008114965-2021-00650
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: SA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: IC71132CA
• Device Lot Number: 30490109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/07/2021
• 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: FIVE UNSPECIFIED MICROWIRES.; UNSPECIFIED MICROCATHETER.