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

Catalog Number IC71132CA

Device Problem Difficult to Remove (1528)

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

Event Date 11/24/2001

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This information was not provided in the reported event or available at the time of report submission.The company is seeking this information through the event investigation.

Event Description

As reported by the field, during treatment to a lesion of an occlusion of the left m1 segment of proximal part, a 132cm embovac 71 aspiration catheter (ic71132ca, lot unknown) and an embotrap ii revascularization device (product/ lot unknown) were used, first pass was made.It was able to be recanalized at tici3.However, the embovac was caught in the ophthalmic artery.After deployment of the stent, the stent as an anchor, and it reached the m1 proximal region.There was no influence on the patient, and after the procedure, consciousness recovered, and right paralysis dramatically improved.It was unclear if a continuous flush was done.

Manufacturer Narrative

Product complaint # (b)(4).Section b3 - event date: 11-24-2021.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 was received indicating no additional intervention was required.No excessive force was applied to the device.There was no alleged product malfunction with the embotrap.The device was inspected for damage prior to use.There was no significant delay in the procedure due to the event.Section e1.Initial reporter phone: (b)(6).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, during treatment to a lesion of an occlusion of the left m1 segment of proximal part, a 132cm embovac 71 aspiration catheter (ic71132ca, lot: unknown) and an embotrap ii revascularization device (product/lot unknown) were used, first pass was made.It was able to be recanalized at tici3.However, the embovac was caught in the ophthalmic artery.After deployment of the stent, the stent as an anchor, and it reached the m1 proximal region.There was no influence on the patient, and after the procedure, consciousness recovered, and right paralysis dramatically improved.It was unclear if a continuous flush was done.Additional information was received indicated no additional intervention was required.No excessive force was applied to the device.There was no alleged product malfunction with the embotrap.The device was inspected for damage prior to use.There was no significant delay in the procedure due to the event.The device was discarded; therefore, no further investigation can be performed.The lot number is not known; therefore, a device history record review cannot be completed.Withdrawal difficulty from vessel after deployment is a potential complication associated with the use of the embotrap ii revascularization device in endovascular mechanical thrombectomy.The instructions for use (ifu) contain the following precautions: carefully inspect all devices prior to use.Verify size, length, and condition are suitable for the specific procedure.Do not use a device that has been damaged in any way; replace with another embovac aspiration catheter.A damaged device may cause complications.Exercise care in handling the embovac catheter to reduce the chance of accidental damage.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint device.However, there are clinical, procedural factors, including vessel characteristics, severe tortuosity, clot burden/characteristics, device interaction, device selection, and operator technique that may have contributed to the event.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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.

• 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 33024
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12955280
• MDR Text Key: 286462990
• Report Number: 3008114965-2021-00636
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• 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,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IC71132CA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2021
• 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
• Treatment: EMBOTRAP.