MAUDE Adverse Event Report: CERENOVUS, INC. IC 71, 132 CM, CE; CATHETER, THROMBUS RETRIEVER

Catalog Number NIC71132C

Device Problems Crack (1135); Stretched (1601); Material Deformation (2976)

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

Event Type  malfunction  

Event Description

The healthcare professional reported that there have been multiple new complaints with the cereglide 71 intermediate catheter (nic71132c) lot number unknown.The issues include cracking at the ¿spider webbing¿ portion of the catheter at the strain relief, as well as ¿crimping¿ and ¿elongating¿ at the proximal portion of the catheter where the rotating hemostasis valve (rhv) is secured.It was stated that the physicians who are experiencing these issues with the cereglide 71 intermediate catheter are not doing anything differently than they do using any other aspiration catheter with the same rhv.On 07-mar-2024, additional / clarifying information was received.Per the information, the reported complaint related to the cereglide 71 intermediate catheters ¿is not specific to any one case or patient, it is just conversational feedback on what the physician is observing with this device when being used in conjunction with other certain devices.There have been no negative effects to any actual case itself, patient, procedure, etc., just the physician¿s observations that the catheter seems to be a little damaged in areas where the rhv is being tightened, indicating maybe more of a user error; however, it still needs to be determined and we are taking the necessary steps in finding out more from the physician including technique, set up, adjunctive devices, etc.¿ the information also indicated that the lot numbers associated with the cereglide 71 intermediate catheter in this complaint are not available; the devices are also not available for return.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section b.3: date of event: the date of the event is not known.Section d.2b: procode is nry/qjp.Section d.4: the expiration date of the device is not known as the device lot number is not available / not reported.Section e.1: the initial reporter phone is not available / reported.Section h.4: the device manufacture date is not known as the device lot number is not available / not reported.Based on complaint information, the device is not available to be returned for analysis.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.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 complaint product available to be returned for analysis, the reported product issue documented in the complaint cannot be confirmed through functional evaluation and analysis.The lot number of the device is not known; therefore, manufacturing documentation review was not performed.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.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.This is one of 5 products involved with the reported complaint.The associated manufacturer report numbers are: 3007628272-2024-00011, 3007628272-2024-00012, 3007628272-2024-00013, 3007628272-2024-00014, and 3007628272-2024-00015.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.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.

• Brand Name: IC 71, 132 CM, CE
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): CERENOVUS, INC.; 6303 waterford district drive; suites 215 & 315; miami FL 33126
• 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 ; 303552-689
• MDR Report Key: 18927226
• MDR Text Key: 337954413
• Report Number: 3007628272-2024-00011
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NIC71132C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• 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