MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL HELIPAQ 18 - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CHE18073030
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This initial mdr will be the only report submitted for this report.The product is expected to be returned for analysis, however it has not been received.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
It was reported by a healthcare professional that a heli 18 cere coil (che18073030/c40080) would not detach during a coiling procedure.They tried everything.The device is being returned for evaluation.
Additional Manufacturer Narrative
This final mdr will be the only report submitted for mfr report #2954740-2017-00282.Conclusion: based on the information, the event could not be confirmed.The product was not returned for analysis; however, 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.Therefore, no corrective actions will be taken at this time.

• Brand Name: HELIPAQ 18 - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle jura ; SZ
• MDR Report Key: 6930389
• Report Number: 2954740-2017-00282
• Device Sequence Number: 1443778
• Product Code: HCG
• UDI-Device Identifier: 00878528000778
• UDI-Public: (01)00878528000778(17)201231(10)C40080
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2017

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: 12/31/2020
• Device Catalogue Number: CHE18073030
• Device Lot Number: C40080
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/12/2017
• Supplement Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 10/09/2017
• Supplement Report FDA Received Date: 11/10/2017
• Patient Sequence Number: 1