MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPAQ CERE 1.5MMX4CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number CDF10015430

Device Problem Break (1069)

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

Event Date 03/09/2022

Event Type  malfunction  

Event Description

As reported by the field, the physician opened the packaging of a deltapaq cere 1.5mmx4cm coil (cdf10015430, 30436875) for inspection and observed that the delivery wire was damaged.No additional information could be provided.The device was not used in patent.A new coil was switched to complete the surgery.

Manufacturer Narrative

Product complaint (b)(4) the purpose of this mdr submission is to report the findings of the device investigation.The embolic coil was found stretched, meeting regulatory reporting criteria.Section d2b ¿ procode: krd/hcg section e1.Initial reporter phone: (b)(6) one non-sterile deltapaq cere 1.5mmx4cm was received in the decontamination pouch.Upon receiving the device, visual inspection was performed, and no anomalies were observed on the device positioning unit (dpu) or any other component.The embolic coil was outside of the introducer.Further analysis under image magnification revealed that the embolic coil was stretched and this remained connected to the resistance heating (rh).The issue reported that a delivery wire (dpu) being damaged was not confirmed as it was found without abnormalities.The damaged condition was not found in the received device.The coil stretching was not originally documented in the complaint, and its exact time of occurrence cannot be determined since no further information was gathered from the customer.It is possible that the coil became stretched during the unit withdrawal due to rotative hemostasis valve (rhv) overtightening or during the post-operative handling of the device.This condition is not considered related to the issue as reported.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at final assembly for coil condition to prevent such damages from leaving the facility.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective and preventive action (capa) activity is required.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) does contain the following recommendations: ¿ if unusual friction is noticed during advancement or retraction of the microcoil system through the introducer, open the rhv main valve, and partially withdraw the distal end of the introducer to expose its tip within the rhv.Tighten the rhv main valve and flush the y-connector of the rhv with sterile saline and verify that fluid exits the slit in the clear portion of the introducer.¿ if unusual friction is still noticed during advancement or retraction of the microcoil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire microcoil system and examine for damage.Replace it with a new microcoil system.If friction still exists, withdraw and examine the delivery catheter system.¿ pulling the exposed microcoil through the rhv grommet may damage the coil.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.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.

• Brand Name: DELTAPAQ CERE 1.5MMX4CM
• 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: 18876396
• MDR Text Key: 337863303
• Report Number: 3008114965-2024-00303
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528007036
• UDI-Public: 00878528007036
• 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
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDF10015430
• Device Lot Number: 30436875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2020
• 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