MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPAQ CERE 1.5MMX6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number CDF100156-30

Device Problem Failure to Advance (2524)

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

Event Date 04/13/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.The initial reporter phone: (b)(6).The initial reporter email address was not available / reported.[conclusion]: the healthcare professional reported that during an endovascular embolization procedure, the physician filled the target aneurysm with the first coil, a 2mm x 6cm deltaplush 10 cerecyte coil (cpl10020630 / s14489) and observed that it was impeded in the introducer.The physician adjusted the coil and pushed it out from the introducer, however, the coil was found to have unraveled / stretched.The physician used the second coil, another 2mm x 6cm deltaplush 10 cerecyte coil (cpl10020630 / s14489), but it was also impeded in the introducer and could not be pushed.A third coil, a 1.5mm x 6cm deltapaq 10 cerecyte coil (cdf10015630 / 30429053) was used but this coil also was impeded in the introducer and could not be pushed out.New devices were used to complete the procedure.There was no report of any patient adverse event or complication.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 1.5mm x 6cm deltapaq 10 cerecyte coil was returned contained in the decontamination pouch.Visual inspection was performed.The embolic coil component was observed to be outside of the introducer.The core wire was observed protruding from the introducer.No other damage was observed.Microscopic inspection was performed.Under magnification, the embolic coil was observed to be stretched, but it still remains attached to the resistance heating (rh) coil.The introducer component was noted to be opened due to a kinked on it.The opened state of the introducer caused the core wire to become protruded in this area of the introducer.The impeded condition of the coil in the introducer as documented in the complaint could not be tested since the conditions in which the coil and the core wire were received prevented the advancement and retraction through the introducer.However, such conditions can be reasonably considered to be secondary to the issue encountered during the procedure.Coil stretching is a known potential issue associated with the use of this device.The instructions for use (ifu) provide proper handling instructions for the device to prevent such issues from occurring.Stretching can occur during procedure handling where force may have been inadvertently applied.The stretched condition of the embolic coil was not originally reported in the complaint.With the limited information available, the root cause of the coil stretching remains unknown.It is possible that a continuous flush had not been done, without an adequate flush, issue such as resistance between the coil and the introducer can arise, which may cause some force to be inadvertently exerted on the device, which can result in the coil becoming stretched.However, this cannot be conclusively determined.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.The customer complaint was confirmed.A review of manufacturing documentation associated with this lot (30429053) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendations: if repositioning of the microcoil is necessary, carefully observe the motion of the microcoil with respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil system.If the microcoil is positioned at a relative sharp angle to the microcatheter, a microcoil may stretch or break as it is being withdrawn.By repositioning the distal tip of the microcatheter at or slightly inside the ostium (neck) of the aneurysm, the microcoil may be more easily funneled back into the microcatheter.If unusual friction is noticed during advancement or retraction of the microcoil system, verify the clear tab is unlocked and pulled out from the re-sheathing tool approximately 1 in.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.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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 three (3) products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2022-00294, 3008114965-2022-00527.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.

Event Description

The healthcare professional reported that during an endovascular embolization procedure, the physician filled the target aneurysm with the first coil, a 2mm x 6cm deltaplush 10 cerecyte coil (cpl10020630 / s14489) and observed that it was impeded in the introducer.The physician adjusted the coil and pushed it out from the introducer, however, the coil was found to have unraveled / stretched.The physician used the second coil, another 2mm x 6cm deltaplush 10 cerecyte coil (cpl10020630 / s14489), but it was also impeded in the introducer and could not be pushed.A third coil, a 1.5mm x 6cm deltapaq 10 cerecyte coil (cdf10015630 / 30429053) was used but this coil also was impeded in the introducer and could not be pushed out.New devices were used to complete the procedure.There was no report of any patient adverse event or complication.The complaint device was returned for evaluation and analysis.Based on the result of the product analysis completed on 04-aug-2022, the event has been deemed reportable as a "malfunction.".

• Brand Name: DELTAPAQ CERE 1.5MMX6CM
• 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: 15170601
• MDR Text Key: 297491586
• Report Number: 3008114965-2022-00528
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528007043
• UDI-Public: 00878528007043
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDF100156-30
• Device Catalogue Number: CDF10015630
• Device Lot Number: 30429053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2022
• Initial Date FDA Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2020
• 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