MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPAQ CERE 1.5MMX2CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number CDF10015230

Device Problems Stretched (1601); Failure to Advance (2524)

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

Event Date 07/18/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section d2b ¿ procode: krd/hcg.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.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.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.

Event Description

As reported by the field, during an endovascular embolization, a deltapaq cere 1.5mmx2cm coil (cdf10015230, 30432657) became impeded in an unspecified microcatheter (mc) and could not pass through the mc.The physician removed the coil from the patient and observed that the coil was unraveled/stretched.A new coil was switched to complete the surgery.The microcatheter was not replaced.There was no patient injury reported.

• Brand Name: DELTAPAQ CERE 1.5MMX2CM
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18640125
• MDR Text Key: 336060572
• Report Number: 3008114965-2024-00179
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K080437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDF10015230
• Device Lot Number: 30432657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2020
• 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: MICROCATHETER (UNSPECIFIED BRAND)