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 04/26/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not 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 supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

As reported by the field, during treatment for an acute ischemic stroke (ais), a 132cn embovac 71 aspiration catheter (ic71132ca, 30582686) was inserted from a bgc catheter.The embovac was used, and the procedure was started with adapt first technique, then the thrombus was removed using a 6mm solitaire.A part of the solitare was stored in the embovac and thrombus was removed with captive technique.The physician was not able to withdraw the embovac, when the physician withdrew the embovac halfway, only the solitaire was removed first, and the solitaire was taken out of the patient¿s body.Subsequently, the physician pulled the embovac, but continued to be unable to pull.When the physician pulled the embovac further, the hand moved, and the tip of the embovac became immobile.It seems to have stretched at this time.The physician thought that the catheter was cut off, but when the embovac was pulled slowly, the tip of the catheter started to move, and there was no problem.Then, the physician proceeded to second pass and beyond with the solitaire and the react 71.The procedure was finally completed with tici 3.After the second pass, the procedure proceeded smoothly.There were no post-procedure changes in the patient.A continuous flush was done.The lesion is ica.Concomitant devices are a guiding catheter (9fr optimo), a guidewire (chikai14), a microcatheter (phenom, medtornic), a y-connector (okay).

Manufacturer Narrative

Product complaint # (b)(4).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.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).Updated sections on this medwatch: b4, g3, g6, h2, h6 and h10.Pre-shipment pictures of the complaint device were received.Based on the visual analysis, it can be noted that the 132cm embovac 71 asp.Catheter was severely damaged.Distal portion of the catheter was deformed (stretched) and curled at 16.5 cm form the distal end.Total stretched portion was 21 cm.Additionally, a crush section was noted at 27 cm from the distal end and a bend section at 31cm from the distal end.Distal end of the catheter was found to be crushed and non-circular along with the adjacent braided mesh.Multiple damages were observed at the braided mesh and hydrophilic coating was observed torn.A manufacturing record evaluation was performed for the finished device 30582686 number, and no non-conformances related to the malfunction were identified.Customer complaint regarding the catheter being stretched was confirmed based on damages observed on the pictures received.These damages are secondary to the withdrawal difficulty reported.However, the root cause of this failure mode remains unknown.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.The mre suggests that the failure reported by the customer could not be related to the manufacturing process.No corrective action will be taken at this time.Further investigation will be performed once the device returns for analysis.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 received indicated that the event did not result in patient injury, death, additional intervention (i.E.Medical or surgical) to preclude serious injury or death, hospitalization, prolongation of existing hospitalization, or permanent disability.The device was removed from the patient without the need for additional intervention.No device fragments remained in the patient.The device was inspected for damage prior to use.There had been no packaging issues.The product labeling was correct.The inner pouch was securely sealed.There was no evidence of device contamination.No foreign material was found.No report that the procedure was prolonged was received.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 for an acute ischemic stroke (ais), a 132cn embovac 71 aspiration catheter (ic71132ca, 30582686) was inserted from a bgc catheter.The embovac was used, and the procedure was started with adapt first technique, then the thrombus was removed using a 6mm solitaire.A part of the solitare was stored in the embovac and thrombus was removed with captive technique.The physician was not able to withdraw the embovac, when the physician withdrew the embovac halfway, only the solitaire was removed first, and the solitaire was taken out of the patient¿s body.Subsequently, the physician pulled the embovac, but continued to be unable to pull.When the physician pulled the embovac further, the hand moved, and the tip of the embovac became immobile.It seems to have stretched at this time.The physician thought that the catheter was cut off, but when the embovac was pulled slowly, the tip of the catheter started to move, and there was no problem.Then, the physician proceeded to second pass and beyond with the solitaire and the react 71.The procedure was finally completed with tici 3.After the second pass, the procedure proceeded smoothly.There were no post-procedure changes in the patient.A continuous flush was done.The lesion is ica.Concomitant devices are a guiding catheter (9fr optimo), a guidewire (chikai14), a microcatheter (phenom, medtornic), a y-connector (okay).Additional information received indicated that the event did not result in patient injury, death, additional intervention (i.E.Medical or surgical) to preclude serious injury or death, hospitalization, prolongation of existing hospitalization, or permanent disability.The device was removed from the patient without the need for additional intervention.No device fragments remained in the patient.The device was inspected for damage prior to use.There had been no packaging issues.The product labeling was correct.The inner pouch was securely sealed.There was no evidence of device contamination.No foreign material was found.No report that the procedure was prolonged was received.Preliminary photo images of the complaint device were captured by the j&j japan affiliates and included in the complaint, in which the device can be observed with a compressed and stretched condition, also the hydrophilic coating could be noted separated from the braided mesh.The device was returned to cerenovus for further evaluation.Upon receiving the device, the presence of hydrophilic coating was confirmed.The device was visually inspected, and the tip of the device was found to be compressed / crushed.Further damage was noted on the braided mesh.It was found to be stretched from the tip to 17 cm from the distal end.Under microscopic magnification, the hydrophilic coating was noted to be separated from the braided mesh portion.Additionally, three (3) kinks were found at 27 cm, 63 cm, and 134.5 cm from the distal end, and a stretching from 22 cm to 32 cm from the distal end.The proximal body of the device was received with two (2) kinks; however, these damages could not be observed in the photos provided, it is likely that the device got kinked during the decontamination or shipment process prior to the physical analysis of the device.The device was confirmed to be within specifications for the hub inner diameter (id) and outer diameter (od), however, the distal inner diameter could not be evaluated due to the compressed condition observed on the tip of the device.Based on the findings during the visual inspection, the customer complaint regarding a stretched condition on the body of the device was confirmed.The hydrophilic coating separation is secondary to the stretching which in turn could have been caused by the removal of the embovac from the patient body, according to the information provided the physician pulled the embovac but continued to be unable to pull.When the physician pulled the embovac further, the hand moved, and the tip of the embovac became immobile; this could explain the crushed condition noted on the tip.The catheter seemed to have stretched at this time too which ultimately led to the hydrophilic coating separation.The stretched condition observed on the braided mesh is related to the customer complaint regarding a withdrawal difficulty.The customer complaint was confirmed.However, there is no indication that the issue reported in the complaint is a result of a defect inherently related to the complaint device.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendations: exercise care in handling the large bore catheter to reduce the chance of accidental damage.Do not advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Torqueing the large bore catheter excessively while kinked may damage the device, resulting in separation of the catheter shaft.Withdraw the entire device (the device, microcatheter, and guidewire) if the device is severely kinked.Assignment of root cause for the events remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failures and damages on the returned system.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 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
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC (MIRAMAR); 3260 executive way; miramar FL 33025
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14356440
• MDR Text Key: 292787561
• Report Number: 3008114965-2022-00332
• 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,Followup,Followup,Followup
• Report Date: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• 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: 30582686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2021
• 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: 6MM SOLITAIRE; 9FR OPTIMO; BGC CATHETER; CHIKAI14 GUIDEWIRE; PHENOM MICROCATHETER, MEDTORNIC; REACT 71; Y-CONNECTOR (OKAY)