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

Catalog Number IC71132CA

Device Problems Difficult to Remove (1528); Stretched (1601)

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

Event Date 09/19/2021

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

As reported by the field, this was a mechanical thrombectomy procedure in the m2 territory with vessel tortuosity both in the approach / access to the neurovasculature and also tortuosity in the neurovasculature was noted.A 132cm embovac 71 aspiration catheter ( ic71132ca, 30456369) was being used over a headway microcatheter to gain access and these were both within a ballast long guide sheath (lgs).Following the use of an embotrap device (which was fully removed following the first pass), the physician reports attempting to withdraw the embovac.However, he states he felt resistance on his first attempt to remove and ¿stretching¿ of the device was suspected (as despite movement proximally the device tip was not moving under x-ray visualisation).Withdrawal of the embovac (ev) device alone was therefore abandoned and instead he opted to pull out the ev and the ballast lgs together ¿ no resistance was felt when this was done and both devices were removed successfully.The procedure was completed using other equipment and no patient consequences were reported.Additional information was received indicating that this was not an adapt (direct aspiration first pass technique) case.No excessive force was applied.The product was removed intact (in one piece) from the patient.No additional intervention was needed to remove the device from the patient.The device(s) were used and prepped as per the instructions for use (ifu).Adequate flush was maintained through the devices.There was a prolongation during the procedure of less than a minute due to the event and it was not considered clinically significant.

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 as reported by the field, this was a mechanical thrombectomy procedure in the m2 territory with vessel tortuosity both in the approach / access to the neurovasculature and also tortuosity in the neurovasculature was noted.A 132cm embovac 71 aspiration catheter (ic71132ca, 30456369) was being used over a headway microcatheter to gain access and these were both within a ballast long guide sheath (lgs).Following the use of an embotrap device (which was fully removed following the first pass), the physician reports attempting to withdraw the embovac.However, he states he felt resistance on his first attempt to remove and ¿stretching¿ of the device was suspected (as despite movement proximally the device tip was not moving under x-ray visualisation).Withdrawal of the embovac (ev) device alone was therefore abandoned and instead he opted to pull out the ev and the ballast lgs together ¿ no resistance was felt when this was done and both devices were removed successfully.The procedure was completed using other equipment and no patient consequences were reported.Additional information was received indicating that this was not an adapt (direct aspiration first pass technique) case.No excessive force was applied.The product was removed intact (in one piece) from the patient.No additional intervention was needed to remove the device from the patient.The device(s) were used and prepped as per the instructions for use (ifu).Adequate flush was maintained through the devices.There was a prolongation during the procedure of less than a minute due to the event and it was not considered clinically significant.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation (mre) was performed for the finished device 30456369 number, and no non-conformances related to the malfunction were identified.With the information available and without the product available for analysis, the reported customer complaints of ¿catheter (body/shaft) - unraveled/stretched¿ and ¿catheter (body/shaft) - withdrawal difficulty-through sheath¿ could not be confirmed.Based on the manufacturing record evaluation, there is no indication that the events were related to the device manufacturing process.Withdrawal difficulty and the stretching of the catheter are potential complications associated with the use of the device.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 events remains speculative and inconclusive, based on the limited information provided and without the return of the complaint device; however, it is possible that clinical and procedural factors, including device manipulation / interaction, vessel characteristics and device selection may have contributed to the reported issues.The stretching condition is likely a contributing factor to the reported issue that was encountered during the attempts to withdrawal the device into the sheath.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
• MDR Report Key: 12648531
• MDR Text Key: 281218779
• Report Number: 3008114965-2021-00520
• 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
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: IC71132CA
• Device Lot Number: 30456369
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2021
• Patient Sequence Number: 1
• Treatment: BALLAST LONG GUIDE SHEATH (LGS).; HEADWAY MICROCATHETER; UNK_THROMBECTOMY NEURAVI