MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL IC 71, 132 CM, CE, ASP. IND.; CATHETER, PERCUTANEOUS

Catalog Number IC71132CA

Device Problems Fluid/Blood Leak (1250); Difficult to Remove (1528); Stretched (1601); Failure to Advance (2524)

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

Event Date 08/30/2023

Event Type  malfunction  

Event Description

As reported by the field, this was a mechanical thrombectomy of the middle cerebral artery for a cerebral infarction.An embovac guide catheter (ic71132ca, 30790679) was used as the instructions for use (ifu).An 8fr sheath was inserted into an emboguard balloon guide catheter (bg8795u, 0000210935), the embovac, a trak21microcatheter (mc) and an embotrap stent retriever.When inserting the emboguard into the sheath, with using the included peel-away sheath, the lumen was too tight and difficult to pass through.Soaked the emboguard in saline and had it coated with a hydrophilic coating, but it was still difficult to insert.Insertion into the sheath was possible without the use of a peel-away sheath.Next, an attempt was made to insert the embovac into the y-connector of a map403 mba¿ hemostasis valve (merit medical) attached to the 95cm emboguard 87 balloon guide catheter, but the embovac did not pass through the peel-away sheath provided with the embovac.After repeated insertion several times and advancing to about halfway up the y-connector, the embovac got stuck, and there was strong resistance to retrieve it, resulting in elongation and damage to the embovac catheter body at 5 cm to 10 cm from the tip.When the lumen was flushed with saline, fluid leaked from the damaged area.Replaced with competitor's catheter and the procedure continued.Legion was crossed with microcatheter, deployment of embotrap and attempted thrombus retrieval using the combined technique resulted in migration of emboguard distal to the lesion.The balloon was in an inflated state with compliance about 0.4 mm and blood flow was blocked.The procedure was completed with the no patient consequence (tici2c).Total 3 passs were done.A continuous flush was done.

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section e1: initial reporter phone: (b)(6).Section h3: 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.Pre-shipment pictures were attached to the complaint file.The embovac catheter and one (1) introducer sheath were returned.Catheter stretching of about 16.5 cm in length was noted starting at 1.5 cm from the distal end.A curvature with kinked marks was found at 112cm.The distal tip was noted to be oval in shape.The coating of the distal aspect that was stretched had a torn appearance as a result of the severe stretching.No other damages were noted.A manufacturing record evaluation was performed for the finished device 30790679 number, and no non-conformances related to the malfunction were identified.The issue reported in the complaint that the catheter did not pass through the peel-away sheath was confirmed based on the appearance of the device as captured in the pictures; repeated insertion and withdrawal through the y-connector resulted in the stretching, which ultimately led to the coating damage and leaking.However, it is unknown if the initial condition of the device may have led to the difficulty experienced during the procedure.This investigation was performed based only on the photos provided.If the product is received after this investigation, an assessment will be performed as per the conditions of the device returned.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.No capa activity is warranted at this time.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 company is seeking this information through the event investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Complaint conclusion: as reported by the field, this was a mechanical thrombectomy of the middle cerebral artery for a cerebral infarction.An embovac guide catheter ((b)(4)) was used as the instructions for use (ifu).An 8fr sheath was inserted into an emboguard balloon guide catheter ((b)(4)), the embovac, a trak21microcatheter (mc) and an embotrap stent retriever.When inserting the emboguard into the sheath, with using the included peel-away sheath, the lumen was too tight and difficult to pass through.Soaked the emboguard in saline and had it coated with a hydrophilic coating, but it was still difficult to insert.Insertion into the sheath was possible without the use of a peel-away sheath.Next, an attempt was made to insert the embovac into the y-connector of a map403 mba¿ hemostasis valve (merit medical) attached to the 95cm emboguard 87 balloon guide catheter, but the embovac did not pass through the peel-away sheath provided with the embovac.After repeated insertion several times and advancing to about halfway up the y-connector, the embovac got stuck, and there was strong resistance to retrieve it, resulting in elongation and damage to the embovac catheter body at 5 cm to 10 cm from the tip.When the lumen was flushed with saline, fluid leaked from the damaged area.Replaced with competitor's catheter and the procedure continued.Legion was crossed with microcatheter, deployment of embotrap and attempted thrombus retrieval using the combined technique resulted in migration of emboguard distal to the lesion.The balloon was in an inflated state with compliance about 0.4 mm and blood flow was blocked.The procedure was completed with the no patient consequence (tici2c).Total 3 passs were done.A continuous flush was done.Pre-shipment pictures were attached to the complaint file.The embovac catheter and one (1) introducer sheath were observed.Catheter stretching of about 16.5 cm in length was noted starting at 1.5 cm from the distal end.A curvature with kinked marks was found at 112cm.The distal tip was noted to be oval in shape.The coating of the distal aspect that was stretched had a torn appearance as a result of the severe stretching.No other damages were noted.A non-sterile embovac guide catheter ((b)(4)) was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed and the presence of hydrophilic coating was confirmed.The distal tip of the catheter was noted to be in an oval shape.The brite tip was noted to be in a stretched condition from 1.5 cm to 13 cm.Two (2) sections of the body shaft were noted with kinked marks; the first at 110 cm, and the second right next to the id band.All measurements were taken from the distal end of the device.Further inspection under microscopic magnification revealed that, as a result of the stretched condition on the brite tip, the coating of the mesh structure was found frayed leaving the braided mesh exposed.The catheter was flushed with a lab-sample syringe and water leakage was noted from the frayed condition of the mesh structure.The catheter was confirmed to be within specifications for the inner diameter (id) and outer diameter (od).A manufacturing record evaluation was performed for the finished device 30790679 number, and no non-conformances related to the malfunction were identified.The issue reported in the complaint that the catheter did not pass through the peel-away sheath was confirmed based on the damaged appearance of the device; repeated insertion and withdrawal through the y-connector resulted in the stretching, which ultimately led to the coating damage and leaking.However, it is unknown if the initial condition of the device may have led to the difficulty experienced during the procedure.According to the risk documentation, a damaged catheter is a potential issue that can occur due to the hemostasis valve not being opened sufficiently and/or the introducer not seated distally enough inside the hemostasis valve during the use of the introducer while inserting the catheter through the hemostasis valve of guide sheath/balloon guide/guide catheter.There is no indication that the issue reported in the complaint results from a defect inherently related to the device.As part of cerenovus quality process all devices are manufactured, inspected, and released to approved specifications.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required.It should be noted that product failure is multifactorial.Although no conclusion could be reached on the cause of the reported event, the instructions for use (ifu) contain the following precautions: ¿ do not advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.¿ exercise care in handling the large bore catheter to reduce the chance of accidental damage.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: IC 71, 132 CM, CE, ASP. IND.
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17772767
• MDR Text Key: 323713152
• Report Number: 3008114965-2023-00672
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K191237
• 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
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: IC71132CA
• Device Lot Number: 30790679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2022
• 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: EMBOGUARD 87, 95 CM; EMBOTRAP STENT RETRIEVER; MAP403 MBA¿ HEMOSTASIS VALVE (MERIT MEDICAL); TRAK21MICROCATHETER; UNSPECIFIED 8FR SHEATH