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

Catalog Number	CDF10015430
Medical Device Problem Codes	Kinked (1339); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mfg.Name - codman & shurtleff, inc.Dba depuy synthes products, inc.Conclusion: the device was returned with its inner pouch.Labeling on the inner pouch matches the product documented in the complaint.The device was returned sheathed.There are no apparent kinks or bends in the dpu core wire.The embolic coil is attached to the dpu and can be seen in the green introducer.There is a kink in the end of the green introducer.The ball tip is intact.There are kinks in the embolic coil.The articulating joint is obscured in the green introducer, but does not appear to be damaged.The v-notch is intact.Advancement of the embolic coil through the green introducer was attempted.The embolic coil could be advanced out of the green introducer.The microcatheter used in the reported event was not returned or identified, so advancement was attempted through a compatible microcatheter (prowler 14).The embolic coil advanced successfully through the microcatheter.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The complaint that the embolic coil was impeded in the microcatheter was not confirmed.The device was successfully advanced through a compatible microcatheter.The kinks observed in the microcoil are evidence that excessive force was applied, possibly in an attempt to overcome resistance.Without the return of the microcatheter, the cause of the complaint cannot be determined.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.This is an initial/final mdr report.
Event or Problem Description
As reported by a healthcare professional, during the procedure, the deltapaq coil (cdf10015430/ s10965) could not be advanced via the microcatheter, and during analysis of the returned product, it was found that the coil was kinked.They used another one to complete the procedure.There was no report of patient injury.Multiple attempts to obtain additional information were unsuccessful.

• Brand Name: DELTAPAQ - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle jura ; SZ
• MDR Report Key: 6954926
• Report Number: 3013875781-2017-00007
• Device Sequence Number: 13818140
• Product Code: HCG
• UDI-Device Identifier: 00878528007036
• UDI-Public: (01)00878528007036(17)210531(10)S10965
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2017

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 Catalogue Number: CDF10015430
• Device Lot Number: S10965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 10/17/2017
• Patient Sequence Number: 1