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

Catalog Number	CDF10015430
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The device was returned for analysis; however, the analysis has not yet been completed.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, a kink was found on the fore-end of the deltapaq coil (b)(4).They used another one to complete the procedure.There was no report of patient injury.It was reported that the device would be returned for analysis.
Additional Manufacturer Narrative
Conclusion: as reported by a healthcare professional, a kink was found on the fore-end of the deltapaq coil (cdf10015430/c20524).They used another one to complete the procedure.There was no report of patient injury.It was reported that the device would be returned for analysis.Multiple attempts to obtain additional information were unsuccessful.The device was returned for analysis.There is a small length of embolic coil exposed from the end of the green introducer.There is a severe kink in the dpu core wire approximately 36 cm from the distal end of the device; the dpu core wire protrudes from the translucent introducer sheath at the kink.There is a slight bend in the dpu core wire approximately 38 cm from the proximal end of the device.The embolic coil was retracted into the translucent introducer, and the length was measured with ruler.The extended coil is 4.2 cm long, which is within the specification range of 4.0 ¿ 4.5 cm for this item number.The ball tip is absent.There are no kinks visible on the embolic coil.The v-notch is undamaged.The embolic coil was advanced out of the green introducer.No kinks or stretched sections of embolic coil can be seen.The rh coil has not received heat and melted.The v-notch is undamaged.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 is kinked is not confirmed.There are no kinked or stretched sections of embolic coil present.However, the evidence of the absent ball tip suggests that there has been damage to the distal end of the embolic coil, which may have presented as a kink and then later have broken off.The severe kink in the dpu core wire is additional evidence of application of excessive force, which may have resulted in the reported issue.The exact sequence of events surrounding the reported incident are not known, so it cannot be determined whether the damage was present before the device was used, or if it became damaged during use.The presence of the ball tip and condition of the embolic coil are verified 100% in-process, and are further inspected in-process at special inspection level.Thus, it is very unlikely that the device left the manufacturing facility with the ball tip missing or kinked.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.

• Brand Name: DELTAPAQ - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6819869
• Report Number: 2954740-2017-00238
• Device Sequence Number: 65489
• Product Code: HCG
• UDI-Device Identifier: 00878528007036
• UDI-Public: (01)00878528007036(17)180711(10)C20524
• 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,Followup
• Report Date (Section B): 08/02/2017

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: 07/11/2018
• Device Catalogue Number: CDF10015430
• Device Lot Number: C20524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2017
• Initial Date Received by Manufacturer: 08/02/2017
• Supplement Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 08/25/2017
• Supplement Report FDA Received Date: 10/18/2017
• Patient Sequence Number: 1