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

Catalog Number IC71132CA

Device Problem Stretched (1601)

Patient Problem Thromboembolism (2654)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Date of event: the date of the event was not reported.The product lot number is not unavailable.The initial reporter phone: (b)(6).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3011370111-2022-00010.Complaint conclusion: it was reported by a healthcare professional that a patient underwent mechanical thrombectomy of a right middle cerebral artery (mca) occlusion and experienced embolization to new territory (ent) during the second pass.A balloon guiding catheter (size/brand/manufacturer not specified) was positioned at the right internal carotid artery (ica).The 132cm embovac 71 aspiration catheter (ic71132ca/unknown lot number) was advanced to the tip of the ica with the aid of a competitor microwire and microcatheter (size/brand/manufacturer not specified).After the lesion was crossed, a 5mm x 37mm embotrap iii revascularization device (et309537/unknown lot number) was deployed at the proximal m2 segment of the mca and retrieved inside the embovac catheter.It was stated that the physician was not able to retrieve it with a first pass nor was there resumption.Outside of the patient¿s body, the stent struts of the embotrap iii were entangled.Photo of the damaged embotrap iii device was provided.It was stated that the physician tried to resolve the issue, but nothing happened.The physician advanced the embovac catheter in the same way for the second pass.¿it was collected after being agglomerated with a different stent retriever (inside the embovac, only the middle of the stent is pulled in.).¿ thrombus was removed and recanalization was successful.Then, the embovac was noted to be unraveled approximately 8cm from the distal tip.Photo of the damaged embovac was provided.Because an embolus migrated into a different vessel during the second pass, additional procedures were required.A competitor aspiration catheter and stent retriever (brand/manufacturer not specified) were used to complete the procedure.Recanalization was achieved.It was further reported that the vascular tortuosity and atherosclerosis ¿were not bad¿.There was a continuous flush maintained through the devices.Additional information received on 19-jan-2022 indicated that there was no resistance encountered during withdrawal of the embotrap into the embovac and/or guide catheter.There was no resistance encountered during withdrawal of the competitor stent retriever into the embovac during the second pass.The damage to the embotrap device occurred outside of the patient.The concomitant devices functioned as expected.The physician did not report any prolongation of procedure.No further information could be obtained.Based on the photos provided, it can be determined that the 132cm embovac 71 asp.Catheter has a compressed and stretched condition on the distal body.No other damages could be noted, only this section of the device was shown in the picture.The manufacturing record evaluation (mre) cannot be performed due to the lot number was not provided.According to the information provided the device was discarded and is not available for analysis.The reported condition ¿catheter (body/shaft)- unraveled/stretched¿ was confirmed since the distal body of the device could be noted stretched.Embolization of thrombus is a known potential complication during mechanical restoration of flow and thrombus removal procedures in which the embovac is used.During these interventional procedures, the devices are advanced and withdrawn through pre-existing thrombotic lesions with risk of embolization of thrombus.Review of the available information suggests that vessel characteristics, patient, and procedural factors may have contributed to the reported ent.The alleged ent necessitated additional thrombectomy passes for restoration of blood flow, and the relationship of the embovac to the reported event cannot be excluded.Catheter unraveling/stretching 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 kinking or 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 this damage is remote.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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

Event Description

It was reported by a healthcare professional that a patient underwent mechanical thrombectomy of a right middle cerebral artery (mca) occlusion and experienced embolization to new territory (ent) during the second pass.A balloon guiding catheter (size/brand/manufacturer not specified) was positioned at the right internal carotid artery (ica).The 132cm embovac 71 aspiration catheter (ic71132ca/unknown lot number) was advanced to the tip of the ica with the aid of a competitor microwire and microcatheter (size/brand/manufacturer not specified).After the lesion was crossed, a 5mm x 37mm embotrap iii revascularization device (et309537/unknown lot number) was deployed at the proximal m2 segment of the mca and retrieved inside the embovac catheter.It was stated that the physician was not able to retrieve it with a first pass nor was there resumption.Outside of the patient¿s body, the stent struts of the embotrap iii were entangled.Photo of the damaged embotrap iii device was provided.It was stated that the physician tried to resolve the issue, but nothing happened.The physician advanced the embovac catheter in the same way for the second pass.¿it was collected after being agglomerated with a different stent retriever (inside the embovac, only the middle of the stent is pulled in.).¿ thrombus was removed and recanalization was successful.Then, the embovac was noted to be unraveled approximately 8cm from the distal tip.Photo of the damaged embovac was provided.Because an embolus migrated into a different vessel during the second pass, additional procedures were required.A competitor aspiration catheter and stent retriever (brand/manufacturer not specified) were used to complete the procedure.Recanalization was achieved.It was further reported that the vascular tortuosity and atherosclerosis ¿were not bad¿.There was a continuous flush maintained through the devices.Additional information received on 19-jan-2022, indicated that there was no resistance encountered during withdrawal of the embotrap into the embovac and/or guide catheter.There was no resistance encountered during withdrawal of the competitor stent retriever into the embovac during the second pass.The damage to the embotrap device occurred outside of the patient.The concomitant devices functioned as expected.The physician did not report any prolongation of procedure.No further information could be obtained.

• 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 & SHURTLEFF, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13306594
• MDR Text Key: 284316419
• Report Number: 3008114965-2022-00043
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: Yes
• 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: 12/30/2021
• 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 III 5 MM X 37 MM; UNSPECIFIED ASPIRATION CATHETER; UNSPECIFIED BALLOON GUIDING CATHETER; UNSPECIFIED MICROCATHETER; UNSPECIFIED MICROWIRE; UNSPECIFIED STENT RETRIEVER
• Patient Outcome(s): Required Intervention