MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CASH 14 CERE 4MMX8.0CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	CRC140408-30
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2020
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 initial reporter phone: (b)(6).The initial reporter email address is not available / reported.[conclusion]: the healthcare professional reported that the 4mm x 8cm cashmere 14 cerecyte coil (crc14040830 / s14576) could not advance within the concomitant microcatheter during the aneurysm embolization procedure.The physician switched to a new coil to complete the procedure.It was indicated that additional information related to the procedure and device issue was not obtainable.There was no report of any patient adverse event or complication as a result of the reported issue.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 4mm x 8cm cashmere 14 cerecyte coil was returned and received contained in a pouch.Visual inspection was performed.The resheathing tool was observed broken in two and the embolic coil is entangled with one of the parts of the resheathing tool.The embolic coil is also in stretched condition.No other damage / anomaly was observed during the visual inspection.The returned device was microscopically inspected.The embolic coil was confirmed to be entangled with one of the pieces of the resheathing tool and was in stretched condition.Functional evaluation could not be performed due to the condition of the device.A review of manufacturing documentation associated with this lot (s14576) 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 reported issue that the complaint coil was impeded in the microcatheter / failure to advance in the microcatheter during the procedure could not be confirmed through functional testing due to the condition of the returned device.During visual and microscopic inspections, the resheathing tool was observed broken in two pieces, the embolic coil was entangled in one of the pieces of the resheathing tool in stretched condition.It is possible that force was exerted on the device when the coil became impeded and could not advance.Though, the exact cause of the condition observed on the returned complaint device cannot be conclusively determined.Coil stretching is a known potential issue associated with the use of this device.The 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 stretched condition of the embolic coil was not originally reported with the complaint.The exact cause of the observed stretched condition could not be conclusively determined; however, it may have been the result of inadvertent force that may have been applied when the coil became impeded in the microcatheter and could not be advanced.Additional information related to the procedure and the device issue was also not available / obtainable.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 4mm x 8cm cashmere 14 cerecyte coil left the manufacturing facility with the embolic coil in a stretched condition, entangled in one of the broken pieces of the resheathing tool as observed on the returned complaint 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 code ¿no device problem found¿ code was used in investigation findings to indicate that the issue reported related to the coil being impeded in the concomitant microcatheter / failure to advance during the procedure could not be confirmed through functional evaluation due to the condition of the returned device.The condition of the returned device may be related to the reported impeded issue, or they may have been due to inadvertent force during handling.The code ¿cause not established¿ was used in investigation conclusions is corresponding to the code ¿no device problem found¿ as related to the originally reported issue in the complaint.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 4mm x 8cm cashmere 14 cerecyte coil (crc14040830 / s14576) could not advance within the concomitant microcatheter during the aneurysm embolization procedure.The physician switched to a new coil to complete the procedure.It was indicated that additional information related to the procedure and device issue was not obtainable.There was no report of any patient adverse event or complication as a result of the reported issue.The 4mm x 8cm cashmere 14 cerecyte coil was returned for evaluation which revealed that the coil was in stretched condition.Based on the product analysis completed on 12 february 2021, this event has been deemed mdr reportable as a ¿malfunction.¿.

• Brand Name: CASH 14 CERE 4MMX8.0CM
• 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: 11324221
• Report Number: 3008114965-2021-00088
• Device Sequence Number: 3283023
• Product Code: HCG
• UDI-Device Identifier: 00878528004486
• UDI-Public: 00878528004486
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072173
• 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: Physician
• 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: 06/30/2022
• Device Model Number: CRC140408-30
• Device Catalogue Number: CRC14040830
• Device Lot Number: S14576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1