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

Catalog Number	DFS10031020
Medical Device Problem Codes	Difficult To Position (1467); Premature Activation (1484); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of one initial/final mdr report being submitted for this complaint with associated mfr# 2954740-2016-00224.(b)(4).Based on the information, the event could not be confirmed.The product was not returned for analysis and a device history record review cannot be completed because the lot for the product is unknown.Since the event could not be confirmed and there is no evidence of a manufacturing-related malfunction, no corrective actions will be taken at this time.
Event or Problem Description
It was reported by the contact at the user facility that the surgeon was packing the last coil a deltapaq 3 x 10 cm coil (dfs10031020/lot unknown) the last 2cm of the coil would not go in.The coil stretched and detached during manipulation.Surgeon completed the procedure using a competitor's stent to plaster the coil to the wall of the artery.The wide neck aneurysm was of size 6mm x 4.5mm.Patient was reported to be fine but carrying a risk of clot formation around the stent as the patient underwent acute stenting.Patient will continue on antiplatelet treatment for 3 months and aspirin for 1 year.Aneurysm was reported to be treated with no residuals.It was reported that the product is not available for analysis.
Additional Manufacturer Narrative
This is one of one final mdr report being submitted for this complaint with associated mfr# 2954740-2016-00224.D4: (b)(4) h4: manufacturing date added h6: dhr performed.H3, h6: the deltapaq will not be returned, therefore the positioning difficulty, the coils stretching, and its unintended detachment cannot be determined.Dhr: a review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Positioning difficulty, unraveled/stretched damages and premature detachment are known potential product malfunctions associated with the use of the codman embolic coils.All products undergo a 100% inspection prior to being released for sale; there is no evidence of a manufacturing issue related to this complaint.Review of the available information suggests that target lesion anatomy and intraprocedural issues may have contributed to the reported events.No further action is required at this time.
Additional Manufacturer Narrative
There is no new information to report at this time.The report is being submitted to correct the sequential numbering of the follow-up reports per fda's request.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

• Brand Name: DELTAPAQ - PLATINUM MICROCOIL
• Common Device Name: 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: 5996538
• Report Number: 2954740-2016-00224
• Device Sequence Number: 98280
• Product Code: HCG
• UDI-Device Identifier: 00878528007715
• UDI-Public: (01)00878528007715(17)170727(10)C12250
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K142429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2016

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: 07/27/2017
• Device Catalogue Number: DFS10031020
• Device Lot Number: C12250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2016
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 10/04/2016
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown