MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPAQ CERE 2MMX8CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number CDF100208-30

Device Problem Separation Failure (2547)

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

Event Date 06/06/2022

Event Type  malfunction  

Event Description

As reported by the field, during a coil embolization, the doctor filled the aneurysm with deltapaq cere 2mmx8cm coil (cdf10020830, lot unknown) and pressed the detachment box to detach it, but the coil could not be detached.The physician retracted the coil and to a new competitor¿s coil to complete the surgery.There was no patient injury reported.

Manufacturer Narrative

Product complaint #
=
> (b)(4).Procode: krd/hcg.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.The company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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).One picture was attached to the complaint file.Based on the visual analysis, one section of the device could be noted, and no damages can be seen.The label was also shown in the picture.Due to the picture, it cannot be determined if the detachment process was initiated since the resistance heat (rh) was not able to be evaluated.No other damages can be seen.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.The customer complaint was not able to be confirmed.This investigation was performed based only on the picture provided.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 pre-deployment electrical testing was performed.The same dcb nor the same cable were used with subsequent coils.The coil was still attached to the coil delivery system when removed from the patient.The coil did not become stretched or damaged.The target vessel/site was the left middle cerebral artery.The procedure was not delayed due to the event.The concomitant devices functioned as expected.Complaint conclusion: as reported by the field, during a coil embolization, the doctor filled the aneurysm with deltapaq cere 2mmx8cm coil (cdf10020830, s14638) and pressed the detachment box to detach it, but the coil could not be detached.The physician retracted the coil to a new competitor¿s coil to complete the surgery.There was no patient injury reported.Additional information received indicated that pre-deployment electrical testing was performed.The same dcb nor the same cable were used with subsequent coils.The coil was still attached to the coil delivery system when removed from the patient.The coil did not become stretched or damaged.The target vessel/site was the left middle cerebral artery.The procedure was not delayed due to the event.The concomitant devices functioned as expected.Picture provided by customer shows only one section of the device, however, the resistance heating (rh) section was not observed on the picture provided.A non-sterile deltapaq cere 2mmx8cm was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and the device was found in good normal conditions (i.E., no kinks, peeling or broken condition were observed).The device was inspected under microscopic magnification, and it was found that the embolic coil is not attached to the rest of the device and it was not returned for evaluation with the rest of the device, also, the resistance heating (rh) was observed overheated, the overheated condition noted on the rh suggests that the detachment cycle was performed several times.The loss condition of the embolic coil is suspected to have occurred sometime during the post-operative handling or decontamination of the microcoil as according to the information provided by the customer the coil was still attached to the coil delivery system when removed from the patient.However, this cannot be conclusively determined.Failure to detach is a known potential issue associated with the use of this device.The instructions for use (ifu) contains several precautions related to this issue and includes instructions for troubleshooting the situation should it be encountered during use.Based on the conditions in which the device was received and the information provided by the customer, the customer¿s complaint regarding a failure to detach was confirmed.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.It should be noted that failure could be caused by multiple factors.The instructions for use (ifu) do contain the following recommendations: verify that the microcoil delivery system is fully connected, and no faults are indicated on the dcb.If a fault exists, reseat all connections between the dpu, the dcb, and the connecting cable.If a fault still persists, replace the connecting cable.If this does not correct the error, replace the dcb.If the microcoil delivery system still continues to have a fault, retrieve the microcoil, re sheathing the microcoil system, and replace it with a new microcoil system.Assignment of root cause for the event 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 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: DELTAPAQ CERE 2MMX8CM
• 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): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14652616
• MDR Text Key: 301122568
• Report Number: 3008114965-2022-00411
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528007104
• UDI-Public: 00878528007104
• Combination Product (y/n): N
• 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: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: CDF100208-30
• Device Catalogue Number: CDF10020830
• Device Lot Number: S14638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2017
• 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: UNK DETACHMENT CONTROL BOX