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

Catalog Number	CDX18073330
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This initial/final mdr will be the only report submitted for mfr report #3013875781-2017-00032.Procode: krd/hcg.(b)(4).This event was deemed mdr reportable based on the failure investigation findings (below).Conclusion: the device was returned in a loop with the embolic coil tangled around the dpu core wire.There is a slight bend in the core wire approximately 104 cm from the proximal end.The resheathing tool is broken.The core wire protrudes from the translucent introducer from the resheathing tool almost to the green introducer.Most of the embolic coil is exposed out the distal end of the green introducer.The ball tip of the embolic coil is intact.The embolic coil is kinked.The proximal end of the embolic coil is inside the green introducer.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-conformances related to device manufacture or inspection.All rejected product was identified as scrap and properly accounted for.The complaint that the device could not be resheathed is confirmed.With the dpu core wire protruded from the translucent introducer sheath distal to the resheathing tool, resheathing cannot occur.The evidence of the broken resheathing tool suggests that excessive force was applied during the attempted resheathing.The force caused the dpu core wire to emerge from the skive of the translucent introducer, which would then prevent any further attempt at resheathing.The exact circumstances of the event are unknown, so the cause of excessive force application cannot be ascertained.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Therefore, no corrective actions will be taken at this time.
Event or Problem Description
It was reported by a healthcare professional that, during a procedure, failure to re-sheath the coil was experienced with a deltamaxx coil (cdx18073330/c39304) and a kink was found on the tip of an envoy guide catheter (67125805d/e11270) upon opening the box.The physician used another of the same size products to successfully complete the procedure.

• Brand Name: DELTAMAXX - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle jura ; SZ
• MDR Report Key: 7040810
• Report Number: 3013875781-2017-00032
• Device Sequence Number: 16476813
• Product Code: KRD
• UDI-Device Identifier: 10878528008580
• UDI-Public: (01)10878528008580(17)201130(10)C39304
• Combination Product (Y/N): N
• Initial Reporter Country: KN
• PMA/510(K) Number: K120274
• 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): 07/05/2017

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: 11/30/2020
• Device Catalogue Number: CDX18073330
• Device Lot Number: C39304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 11/17/2017
• Patient Sequence Number: 1