MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPAQ CERE 1.5MMX2CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	CDF100152-30
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.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.A review of manufacturing documentation associated with this lot (s10905) 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 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 1.5mm x 2cm deltapaq 10 cerecyte coil (cdf10015230 / s10905) was the first coil used; when the physician attempted to detach the coil, the audible beep of the detachment cycle was heard, but when the physician was retrieving the delivery system, the coil failed to detach.The physician used another 1.5mm x 2cm deltapaq 10 cerecyte coil as a replacement coil and the procedure was successfully completed.There was no report of any patient complication or adverse event.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the returned complaint device on 09/01/2020; the returned product underwent evaluation and analysis.[conclusion]: the healthcare professional reported that during the procedure, the 1.5mm x 2cm deltapaq 10 cerecyte coil (cdf10015230 / s10905) was the first coil used; when the physician attempted to detach the coil, the audible beep of the detachment cycle was heard, but when the physician was retrieving the delivery system, the coil failed to detach.The physician used another 1.5mm x 2cm deltapaq 10 cerecyte coil as a replacement coil and the procedure was successfully completed.There was no report of any patient complication or adverse event.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 1.5mm x 2cm deltapaq 10 cerecyte coil was returned contained in a pouch.Visual inspection was performed.The returned complaint device was observed to be in good, normal condition with no observable appearance of damage or anomaly.The device underwent a microscopic inspection.The embolic coil was observed in good, normal condition.Functional evaluation: the resistance of the 1.5mm x 2cm deltapaq 10 cerecyte coil was measured with multimeter.The initial resistance was measured to be 53.9 o; this is within the specification range of 48.5 o ¿ 56.0 o.The device was then connected to a lab sample detachment control box dcb00000500 (dcb) with a lab sample enpower control cable and the power was turned on.The system ready light became illuminated.The embolic coil was immersed in warmed enzyme solution, the detach button was pressed.The embolic coil was detached.A review of manufacturing documentation associated with this lot (s10905) 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 complaint documented that during the procedure, the complaint coil was the first coil chosen for the procedure, but when the physician attempted to detach the coil, the audible signal of the detachment cycle was heard, but when the physician retrieved the delivery system, the coil was reported as failed to detach.The complaint coil was returned for evaluation and functional analysis.There was no outward appearance of damage and no anomaly noted.The embolic coil was in good condition.The returned device underwent functional testing after electrical parameters were measured and confirmed to be within the specification range, the coil was detached without any issue.The reported issue in the complaint was not confirmed based on the functional testing performed on the returned device.Based on the device history record 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.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.

• Brand Name: DELTAPAQ CERE 1.5MMX2CM
• 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: 10393929
• Report Number: 3008114965-2020-00299
• Device Sequence Number: 2060653
• Product Code: HCG
• UDI-Device Identifier: 00878528007012
• UDI-Public: 00878528007012
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K080437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2020

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: 05/31/2021
• Device Model Number: CDF100152-30
• Device Catalogue Number: CDF10015230
• Device Lot Number: S10905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 09/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1