MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPAQ CERE 3MMX8CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number CDF100308-30

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2020

Event Type  malfunction  

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.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ 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 (s11444) 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 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 the procedure, the 3mm x 8cm deltapaq 10 cerecyte coil (cdf10030830 / s11444) was used as a filling coil, but the physician did not like the shape of the coil deployment and decided to remove the coil.During the resheathing attempt, the coil introducer failed to be re-zipped.The physician used another 3mm x 8cm deltapaq 10 cerecyte coil and the procedure was successfully completed.There was no report of any patient adverse event or complication.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received by the product analysis lab on 3/25/2020.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during the procedure, the 3mm x 8cm deltapaq 10 cerecyte coil (cdf10030830 / s11444) was used as a filling coil, but the physician did not like the shape of the coil deployment and decided to remove the coil.During the resheathing attempt, the coil introducer failed to be re-zipped.The physician used another 3mm x 8cm deltapaq 10 cerecyte coil 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 product was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 3mm x 8cm deltapaq 10 cerecyte coil was received contained in a pouch.Visual inspection was performed.The coil introducer was partially zipped, kinked and slightly bent.Microscopic inspection was performed.The embolic coil was observed in good condition.No other damage was observed.Functional testing was not performed as the coil introducer was observed damaged.The observed damage on the coil introducer may have contributed to the reported resheathing issue documented in the complaint.A review of manufacturing documentation associated with this lot (s11444) 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 the 3mm x 8cm deltapaq 10 cerecyte coil was chosen to be a filling coil, but the physician did not like the shape of the coil deployment and decided to remove the coil.During the resheathing attempt, the coil introducer failed to be rezipped.While the re-zipping issue was not confirmed through functional evaluation as the condition of the coil introducer precluded the device from being functionally tested; however, the issue was confirmed based on the observation that the coil introducer was damaged.Positioning difficulty / poor conformability is a known potential issue associated with the use of the device.Factors such as the shape of the target lesion, tortuosity of the parent vessel may have contributed to the way the coil is positioned and/or conforms when it gets delivered to the target site.With the limited information the reported customer complaint could not be confirmed.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.Updated sections: g.4, g.7, h.2, h.3, h.6, and h.10.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 3MMX8CM
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 9844915
• MDR Text Key: 211348376
• Report Number: 3008114965-2020-00051
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528007203
• UDI-Public: 00878528007203
• Combination Product (y/n): N
• PMA/PMN Number: K080437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: CDF100308-30
• Device Catalogue Number: CDF10030830
• Device Lot Number: S11444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Date Manufacturer Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1