MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPAQ - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number CDF10015230

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2017

Event Type  malfunction  

Manufacturer Narrative

This initial mdr will be the only report submitted for mfr report #2954740-2017-00240.The product has been forwarded to codman for evaluation and testing, however the analysis has not been completed.Additional information will be submitted within 30 days of receipt.

Event Description

It was reported by a healthcare professional that a deltapaq coil (cdf10015230/ c41241) could not be detached during a procedure.The physician used another one to complete the procedure.There was no report of patient injury.

Manufacturer Narrative

Conclusion: the device was returned with an inner pouch.The labeling on the inner pouch matches the product documented on the complaint.The device is fully sheathed.The embolic coil is located near the distal end of the green introducer.There are no apparent kinks or bends in the dpu core wire.The ball tip is intact.There are no kinks or stretched sections of embolic coil.The articulating joint is intact.The v-notch is undamaged.The embolic coil was advanced out of the introducer preparatory to testing detachment.The rh coil has not received heat and melted.The resistance of the embolic coil system was tested and was found to be within the specification range of 48.5 ¿ 56.The device was connected to dcb with enpower connecting cable and turned on.The system ready light illuminated.The embolic coil was placed in warmed enzyme solution and detachment was attempted.The embolic coil successfully detached from the dpu.The complaint that the embolic coil failed to detach is not confirmed.Under laboratory conditions, the embolic coil detached properly.There is no observed damage to the device that could have prevented detachment.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformance's related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Therefore, no corrective actions will be taken at this time.

• Brand Name: DELTAPAQ - CERECYTE MICROCOIL
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• Manufacturer Contact: karen anigbo ; 821 fox lane; san jose, CA 95131 ; 5088288374
• MDR Report Key: 6821736
• MDR Text Key: 83687383
• Report Number: 2954740-2017-00240
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528007012
• UDI-Public: (01)00878528007012(17)210228(10)C41241
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K080437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: CDF10015230
• Device Lot Number: C41241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1