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

Catalog Number	DMX18073320
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common device name: krd/hcg.(b)(4).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, during a large avm fistula embolization or an unspecified vessel, the deltamaxx coil (dmx18073320/ p11615) did not deploy.The procedure was completed with a same/like device.There were 11 codman coils deployed before the coil and 37 coils were deployed after the coil.Only two microcatheters and 2 control cables were used during the procedure and all other coils were deployed normally.There was no resistance between the coil and microcatheter, and a continuous flush had been maintained through the microcatheter.The microcatheter did not appear damaged, and the coil was removed from the microcatheter, without premature detachment.The same enpower cable and detachment control device were used to detach subsequent coils.A pre-deployment electrical check had been performed.Low battery light or fault light had not bee seen during the case.Upon pressing the power button, all lights illuminated and the green system ready light illuminated.All connections appeared to fit properly without application of excessive force.There was no adverse consequence to the patient and no clinically significant delay in the procedure.Information regarding patient age, gender and medical history could not be obtained.
Additional Manufacturer Narrative
Conclusion: as reported by a healthcare professional, during a large avm fistula embolization or an unspecified vessel, the deltamaxx coil (dmx18073320/ p11615) did not deploy.The procedure was completed with a same/like device.There were 11 codman coils deployed before the coil and 37 coils were deployed after the coil.Only two microcatheters and 2 control cables were used during the procedure and all other coils were deployed normally.There was no resistance between the coil and microcatheter, and a continuous flush had been maintained through the microcatheter.The microcatheter did not appear damaged, and the coil was removed from the microcatheter, without premature detachment.The same enpower cable and detachment control device were used to detach subsequent coils.A pre-deployment electrical check had been performed.Low battery light or fault light had not been seen during the case.Upon pressing the power button, all lights illuminated and the green system ready light illuminated.All connections appeared to fit properly without application of excessive force.There was no adverse consequence to the patient and no clinically significant delay in the procedure.Information regarding patient age, gender and medical history could not be obtained.It was reported that the device would be returned for analysis.The deltamaxx was returned for analysis.The unspecified enpower detachment control box (dcb), the unknown connecting cable, and the unidentified microcatheter were not returned.Concerning cleanliness only, the microcoil system was returned in almost pristine condition.The system was either not used or was cleaned before being returned which may have produced further damage.The detachment fiber did not receive heat and melt.The device positioning unit (dpu) passed electrical testing with resistance at 52.0 ohms (range 48.5/56.0), and the lab sample enpower and cable systems ready green light illuminated.The coil detached on the first detachment cycle.Post-detachment inspection found that the enpower systems ready green light remained illuminated and the resistance passed at 52.1 ohms.The field complaint of the coils non-detachment could not be duplicated.Post-detachment inspection found that the detachment fiber received heat and melted as designed.No manufacturing defects were found.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.The deltamaxx coil non-detachment was not confirmed.The dpu passed electrical testing and the coil detached on the first detachment cycle, therefore the root cause of the coils non-detachment cannot be determined.In addition, without the return of the complete detachment system and the unidentified microcatheter used in the procedure it cannot be determined if these components contributed to the complaint event.Since there was no evidence of a manufacturing issue related to the event, no corrective actions will be taken at this time.

• Brand Name: DELTAMAXX - PLATINUM MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 5996583
• Report Number: 2954740-2016-00225
• Device Sequence Number: 19102140
• Product Code: HCG
• UDI-Device Identifier: 10878528001727
• UDI-Public: (01)10878528001727(17)201231(10)P11615
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 09/12/2016

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: 12/31/2020
• Device Catalogue Number: DMX18073320
• Device Lot Number: P11615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2016
• Supplement Report FDA Received Date: 10/19/2016
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENPOWER DCB AND CABLE (CATALOG/LOT UNK)