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

Catalog Number	CDF10030430
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of one initial mdr report being submitted for this complaint with associated mfr# 2954740-2017-00006.(b)(4).The product is available for evaluation and testing, however the analysis has not been completed.Additional information will be submitted within 30 days of receipt.No conclusions are made at this time.
Event or Problem Description
As reported by health care professional, during a coil embolization procedure a deltpaq cere 3m x 4 cm ((b)(4)) coil failed to detach.The coil was withdrawn from the patient and was still attached to the delivery system; a new coil was used to complete the procedure.The pre-deployment electrical check was performed and the green system ready light illuminated.The detachment light did not illuminate and the audible signal did not beep.All connections appeared to fit properly without application of excessive force.The same connecting cable and dcb were used successfully with subsequent coils.There were no intra or post procedural complications or delays related to device or reported event.The patient was a (b)(6) year old female.There was no report on the patient injury and patient outcome was reported to be fine.It was initially reported that the complaint product is available for return.
Additional Manufacturer Narrative
This is final mdr report being submitted for this complaint with associated mfr# 2954740-2017-00006.Limited information was received.The unidentified detachment control box (dcb) and the connecting cable were not returned.The unidentified microcatheter was 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.It is also unknown if the device was improperly handled for returned packaging or was further manipulated and/or inspected post-procedurally.In addition, any trace or other evidence that may have been complaint related may have been altered or removed prior to being returned due to post-procedural handling, cleaning, and packaging.All location and measurement callouts are approximate and for reference only.The returned coil with an unknown lot number is confirmed as a 3mmx4.0cm coil.The reported lot # g29481 does not exist.The detachment fiber did not receive heat and melt.The coil was found to be undamaged.The device positioning unit (dpu) failed electrical testing with resistance at 0.0 ohms (range 48.5/56.0) and the test enpower and cable systems ready green light failed to illuminate (deltapaq ifu).The complaint of the coils non-detachment is confirmed.The dpu failed electrical testing.While the exact root cause cannot be determined, the evidence as received highly suggests that the most likely contributing factor to the coil¿s non-detachment may have been a fracture of the solder connection inside the resistive heating coil.The circumstances of how and when this damage occurred cannot be determined as all microcoil systems are electrically tested prior to final packaging.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 had any additional contributions to the complaint event.The reported lot g29481 does not exist; therefore the manufacturing records of this unknown lot number could not be reviewed.Based on the information and the analysis, the event was confirmed, the contributing factor to the coil¿s non-detachment may have been a fracture of the solder connection.Without return of concomitant products it cannot be determined if those components had any additional contributions to the complaint event.Additionally, a device history record review cannot be completed because the lot for the complaint product is unknown.Therefore, 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: 6233660
• Report Number: 2954740-2017-00006
• Device Sequence Number: 426136
• Product Code: HCG
• UDI-Device Identifier: 00878528007180
• UDI-Public: (01)00878528007180
• 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): 12/19/2016

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 Catalogue Number: CDF10030430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2017
• Supplement Report FDA Received Date: 01/17/2017
• Patient Sequence Number: 1
• Patient Age: 48 YR