MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAMAXX CERECYTE 18SYS 24X60; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	CDX182460-30
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.Procode is krd/hcg.The name, phone and email address of the initial reporter are not available / reported.[conclusion]: the healthcare professional reported that the 24mm x 60cm deltamaxx cerecyte® coil (cdx18246030 / c38840) was the first coil chosen for the procedure.The physician decided to retract the coil for redeployment, (the second attempt to better position the coil).During the resheathing, the coil introducer failed to be re-zipped.The physician used another 24mm x 60cm deltamaxx cerecyte® coil as replacement and the procedure was successfully completed.There was no report of any patient adverse event or complication.Multiple attempts to obtain additional information related to the procedure and the reported device issue were unsuccessful.If additional information is received at a later date, this file will be updated accordingly.The device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 24mm x 60cm deltamaxx cerecyte® coil was received contained in a pouch.Visual inspection was performed.Only the emboli coil was returned for evaluation.Microscopic inspection was performed.The embolic coil was observed kinked and stretched.There are residues of dried blood observed on the coil.No other additional damages or anomalies were observed.A review of manufacturing documentation associated with this lot (c38840) 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.The resheathing issue documented in the complaint could not be confirmed; only the embolic coil was returned for evaluation.The embolic coil was in kinked and stretched condition; this observed condition confirmed the reported issue related to the positioning difficulty.Coil stretching and kinking are known potential issues associated with the use of the device.The instruction for use provides proper handling instructions for the device to prevent issues such as stretching and kinking from occurring.The stretched and kinked conditions observed on the embolic coil of the returned device were not originally reported with the complaint.Stretching can occur during attempts to withdrawal the coil against resistance.Kinking can be due to force that may have been applied inadvertently.With the limited information available related to the procedure and the reported device issue, the exact cause of the stretched and kinked condition of the coil cannot be conclusively determined; however, it may have been the result of inadvertent force that may have been applied during the attempt to resheath the coil where it was reported that the coil introducer failed to be re-zipped.Based on the review of the manufacturing documentation, there is no indication that the event is related to the device manufacturing process.In addition, devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the 24mm x 60cm deltamaxx cerecyte® coil left the manufacturing facility with the embolic coil in the observed stretched and kinked conditions.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.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 or Problem Description
The healthcare professional reported that the 24mm x 60cm deltamaxx cerecyte® coil (cdx18246030 / c38840) was the first coil chosen for the procedure.The physician decided to retract the coil for redeployment, (the second attempt to better position the coil).During the resheathing, the coil introducer failed to be re-zipped.The physician used another 24mm x 60cm deltamaxx cerecyte® coil as replacement and the procedure was successfully completed.There was no report of any patient adverse event or complication.Multiple attempts to obtain additional information related to the procedure and the reported device issue were unsuccessful.If additional information is received at a later date, this file will be updated accordingly.The complaint device was returned for evaluation.During the visual / microscopic inspection of the returned device, the embolic coil was observed stretched and kinked.Based on the product analysis 12/28/2020, this event has been deemed mdr reportable as a ¿malfunction.¿.

• Brand Name: DELTAMAXX CERECYTE 18SYS 24X60
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 11083620
• Report Number: 3008114965-2020-00610
• Device Sequence Number: 11781809
• Product Code: KRD
• UDI-Device Identifier: 10878528008757
• UDI-Public: 10878528008757
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K120274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: CDX182460-30
• Device Catalogue Number: CDX18246030
• Device Lot Number: C38840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 12/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1