MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPL CERE COIL 10 SYS 1.5X3; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	CPL100153-30
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Stretched (1601); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2020
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.The name, phone and email address of the initial reporter are not available / reported.[conclusion]: the healthcare professional reported that during the procedure, the physician attempted to resheath the 1.5mm x 3cm deltaplush 10 cerecyte coil (cpl10015330 / l15226) after deciding that the coil was not the proper choice for the procedure, but the coil failed to resheath and the introducer sheath became split.There was no resistance between the complaint coil and the concomitant excelsior® sl-10® microcatheter (stryker); there was no issue with the microcatheter.The coil was removed from the patient without any intervention and without loss of target position.There was no blood flow restriction / reduction as a result of the reported event.There was no report of any patient adverse event or complication.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 1.5mm x 3cm deltaplush 10 cerecyte coil was received contained in a pouch.Visual inspection was performed.The device positioning unit (dpu) was observed protruding from the introducer; it was also kinked at 32cm from the proximal end.The embolic coil was mechanically detached and in stretched condition.No other damage was observed during the visual inspection.Microscopic inspect was performed.The embolic coil component was observed mechanically detached from the rest of the device; it is also observed in stretched condition.Functional evaluation could not be performed due to the embolic coil being in stretched condition and already detached from the rest of the device.A review of manufacturing documentation associated with this lot (l15226) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The issue reported in the complaint related to the resheathing failure could not be replicated in the laboratory setting.The dpu was observed kinked and protruding from the introducer; the embolic coil was stretched and already mechanically detached on the returned device.The observed condition of the embolic coil suggest force may have been exerted on the device.The condition observed confirmed the resheathing failure issue reported.The issue reported that the introducer sheath was split was confirmed.The dpu was observed protruding from the introducer, this is related to the sheath being split.Coil stretching is a known potential issue associated with the use of this device.The instructions for use (ifu) provides proper handling instructions for the device to prevent such issue from occurring.Stretching can occur during procedure handling where force may have been inadvertently applied.The embolic coil was also observed mechanically detached from the rest of the complaint device.The stretched and mechanically detached state of the embolic coil was not originally reported in the complaint.The exact cause of the stretched and mechanically detached 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 which was reported to have failed.The introducer sheath was also reported as split.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the 1.5mm x 3cm deltaplush 10 cerecyte coil left the manufacturing facility with the embolic coil stretched and mechanically detached from the device.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 during the procedure, the physician attempted to resheath the 1.5mm x 3cm deltaplush 10 cerecyte coil (cpl10015330 / l15226) after deciding that the coil was not the proper choice for the procedure, but the coil failed to resheath and the introducer sheath became split.There was no resistance between the complaint coil and the concomitant excelsior® sl-10® microcatheter (stryker); there was no issue with the microcatheter.The coil was removed from the patient without any intervention and without loss of target position.There was no blood flow restriction / reduction as a result of the reported event.There was no report of any patient adverse event or complication.The complaint device was returned for evaluation.During the visual / microscopic inspection of the returned device, the embolic coil was observed in stretched condition and mechanically detached.Based on the product analysis on 10 february 2021, this event has been deemed mdr reportable as a ¿malfunction.¿.

• Brand Name: DELTAPL CERE COIL 10 SYS 1.5X3
• 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: 11311793
• Report Number: 3008114965-2021-00083
• Device Sequence Number: 16377538
• Product Code: HCG
• UDI-Device Identifier: 00878528008194
• UDI-Public: 00878528008194
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K083646
• 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): 12/27/2020

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: 02/29/2024
• Device Model Number: CPL100153-30
• Device Catalogue Number: CPL10015330
• Device Lot Number: L15226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1