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

Catalog Number IC71132CA

Device Problems Break (1069); Difficult to Remove (1528)

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

Event Date 12/10/2021

Event Type  malfunction  

Event Description

The healthcare professional reported that during a thrombectomy procedure, a132cm embovac 71 aspiration catheter (ic71132ca / 30578753) was damaged during the procedure targeting an occlusion located on the left m1 segment in an (b)(4) female patient.It was reported that once the embovac was positioned at the m1 origin where the clot was located, the guiding catheter was in the internal carotid artery (ica) curve.While retrieving the embovac in aspiration in order to remove the clot, the interaction between the embovac and the neuron max® 088 sheath (penumbra) caused the embovac damage.This generated high friction and difficulties in retrieving the embovac.In order to remove it, both the neuronmax and the embovac were retrieved.There was a 7-minute delay to the procedure but the procedure was successfully completed.There was no report of any patient adverse event or complication.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, and ethnicity were not provided.The initial reporter phone is not available / reported.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.A review of manufacturing documentation associated with this lot (30578753) 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.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 11-jan-2022, and to report that multiple attempts to obtain product for analysis were unsuccessful.If product is returned or information provided at a later date, the file will be updated accordingly.[conclusion]: the healthcare professional reported that during a thrombectomy procedure, a132cm embovac 71 aspiration catheter (ic71132ca / 30578753) was damaged during the procedure targeting an occlusion located on the left m1 segment in an 84-year-old female patient.It was reported that once the embovac was positioned at the m1 origin where the clot was located, the guiding catheter was in the internal carotid artery (ica) curve.While retrieving the embovac in aspiration in order to remove the clot, the interaction between the embovac and the neuron max® 088 sheath (penumbra) caused the embovac damage.This generated high friction and difficulties in retrieving the embovac.In order to remove it, both the neuronmax and the embovac were retrieved.There was a 7-minute delay to the procedure but the procedure was successfully completed.There was no report of any patient adverse event or complication.On 11-jan-2022, additional information was received.The information indicated that the vessels were not excessively tortuous nor presented acute bends.The procedure was an adapt (direct aspiration first pass technique) case.The device was not snaked (advanced without wire / microcatheter); the device was advanced with an axs offset catheter (stryker) and a synchro® 0.014¿ guidewire (stryker).Continuous flush was maintained.There was no resistance / friction when the embovac was initially introduced into the neuron max; the information indicated that the neuron max was used as a guiding catheter.It was reported that once the embovac was positioned at the m1 origin, where the clot was located, the long sheath introducer (neuronmax 0.088¿ 100cm) was in the internal carotid artery (ica) curve.While retrieving the embovac in aspiration in order to remove the clot, the interaction between the embovac and the neuron max caused the embovac damage.The information indicated that ¿it seems the neuron max has cut the embovac.¿ due to the damaged embovac, high friction was generated making difficult to remove the retrieve the embovac.In order to remove the embovac, both the neuron max and the embovac were retrieved.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30578753) 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.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.Assignment of root cause for the event remains speculative and inconclusive, based on the information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size / vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.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.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 02-feb-2022.On 02-feb-2022, additional / clarification information was received indicating that the event reported in medwatch 3500a report: 3008114965-2021-00745 (manufacturer¿s ref.No:(b)(4) belongs to the event reported in medwatch 3500a report: 3008114965-2021-00665 (manufacturer¿s ref.No: (b)(4).All forthcoming additional information will be documented and reported under medwatch 3500a report: 3008114965-2021-00665 (manufacturer¿s ref.No:(b)(4).Updated sections: b.4, g.3, g.6, h.2, and h.10.

• 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: 13144483
• MDR Text Key: 290557592
• Report Number: 3008114965-2021-00745
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: IC71132CA
• Device Lot Number: 30578753
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2021
• 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: AXS OFFSET CATHETER (STRYKER); NEURON MAX® 088 SHEATH (PENUMBRA); SYNCHRO® 0.014¿ GUIDEWIRE (STRYKER)
• Patient Age: 84 YR
• Patient Sex: Female