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

Catalog Number IC71132CA

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 12/02/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.The name, phone and email address of the initial reporter are not available / reported.Initial reporter facility name: (b)(6).[conclusion]: the healthcare professional reported that during a thrombectomy procedure, targeting a thrombus/occlusion at the ic top.The complaint 132cm embovac 71 aspiration catheter (ic71132ca / 30546092) was used to remove the thrombus; no stents were used.A concomitant trevo trak 21 microcatheter (stryker) was used and the complaint device followed the microcatheter.A pump tube for cat was connected to the y-connector and suction was performed.A thrombolysis in cerebral infarction (tici) score of 3 was achieved after the first pass.Recanalization was obtained, but the hub connection part which is the junction part of the orange and the embovac shaft was becoming broken from the time of the setting; blood was seeping out.Suction was performed but the hub connection part became fractured.The physician managed to support the broken / fractured area with his fingers and continued to use the device.It was not known if continuous flush was maintained.There was no report of any patient injury.It was reported that the product is not available for return; however a photo of the complaint device was provided by the hospital facility.A singular photo of the complaint device was included in the complaint.The product analysis lab reviewed the photo.The observation is documented below.[photo analysis]: based on the photo of the complaint device, the body of the 132cm embovac 71 aspiration catheter could be noted to be partially separated from the id band, which is next to the hub.Only this section of the device is captured in the photo.No other damages were observed.The reported issue that the hub connection part became broken / fractured was confirmed since the proximal body of the device could be noted to be partially separated from the id band; however, the exact time when this occurred cannot be conclusively determined.A review of manufacturing documentation associated with this lot (30546092) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Based on the manufacturing record evaluation, the reported issue are not related to the manufacturing process.The complaint information indicated that the device was not available to be returned for analysis.Product evaluation and analysis cannot be conducted as the product was not available to be returned.Determination of causes and possible contributing factors could not be made.As such, the investigation will be closed.With the information available and without the product available for analysis, the reported event could not be confirmed through the product analysis process.However, the photo of the complaint was reviewed and based on the photo, the reported issue in the complaint was confirmed.The exact cause of the issue cannot be conclusively determined.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

The healthcare professional reported that during a thrombectomy procedure, targeting a thrombus/occlusion at the ic top.The complaint 132cm embovac 71 aspiration catheter (ic71132ca / 30546092) was used to remove the thrombus; no stents were used.A concomitant trevo trak 21 microcatheter (stryker) was used and the complaint device followed the microcatheter.A pump tube for cat was connected to the y-connector and suction was performed.A thrombolysis in cerebral infarction (tici) score of 3 was achieved after the first pass.Recanalization was obtained, but the hub connection part which is the junction part of the orange and the embovac shaft was becoming broken from the time of the setting; blood was seeping out.Suction was performed but the hub connection part became fractured.The physician managed to support the broken / fractured area with his fingers and continued to use the device.It was not known if continuous flush was maintained.There was no report of any patient injury.It was reported that the product is not available for return; however a photo of the complaint device was provided by the hospital facility.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 31-jan-2022.[additional information]: on 31-jan-2022, additional information was received.The information indicated that there was no difficulty encountered flushing the device during the preparation.No further information was obtained related to how the procedure was completed, ¿but the complaint device was managed to be used somehow.¿ there was no clinically significant delay in the procedure as a result of the reported event.E.1: the initial reporter phone: (b)(6).The initial reporter email address is not available / reported.Updated sections: b.4, e.1, e.3, g.3, g.6.H.2, and h.10.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• 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 33025
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-868
• MDR Report Key: 13044350
• MDR Text Key: 290452930
• Report Number: 3008114965-2021-00623
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: IC71132CA
• Device Lot Number: 30546092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2021
• 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: 8FR OPTIMO¿ BALLOON GUIDE CATHETER (TOKAI MEDICAL); TREVO TRAK 21 MICROCATHETER (STRYKER)