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

Catalog Number	CDF10020230
Medical Device Problem Codes	Positioning Failure (1158); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2016
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# 2954740-2016-00214.(b)(4).Very limited information was received.The unidentified detachment control box (dcb) and the unidentified connecting cable were not returned.The unidentified microcatheter and the rotating hemostatic valve (rhv) 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.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 detachment fiber did not receive heat and melt.The coil was stretched and the stretch resistance suture was completely severed including the ball tip and was not returned.No manufacturing defects were found.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.While the root cause of the coils non-detachment cannot be determined, the most likely contributing factor may have been due to wiring and/or solder joint connection damage.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 identification or the return of the complete detachment system and the unknown microcatheter used in the procedure, it cannot be determined if these components contributed to the complaint event.The complaint of the coil stretching is confirmed.While the root cause of the coil stretching cannot be determined, the most likely contributing factor may have been due to the distal tip of the coil becoming temporarily anchored on an unknown source and location.During coil removal, the anchored coil stretched and severed the stretch resistance suture.In addition, without the identification or the return of the unknown microcatheter and the rhv used in the procedure, it cannot be determined if these components contributed to the complaint event.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.Based on the information and the analysis, the event was confirmed.The root cause of the reported event could not be determined however procedural factors most likely contributed to the event.Without return of concomitant products it cannot be determined if those components had any additional contributions to the complaint event.Additionally, review of 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.
Event or Problem Description
It was reported by a contact at the user facility that during a coil embolization procedure the deltapaq coil (cdf10020230/c24536) could not be detached.All connections appeared to fit properly without application of excessive force and a pre-deployment electrical check was performed.The coil was still attached to the delivery system when removed from the patient; however the coil was found to be stretched.A new coil was used to complete the procedure.The same connecting cable and detachment control box were used with subsequent coils.The reported event did not require an exchange of the microcatheter.There were no intra or post procedural complications or surgical delays related to device or reported event.There were no damages noted on the complaint coil prior to use.There was no report on patient injury.It was initially reported that the product is available for analysis.

• 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: 5973674
• Report Number: 2954740-2016-00214
• Device Sequence Number: 16164454
• Product Code: HCG
• UDI-Device Identifier: 00878528007067
• UDI-Public: (01)00878528007067(17)190217(10)C24536
• 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
• Report Date (Section B): 08/31/2016

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: 02/17/2019
• Device Catalogue Number: CDF10020230
• Device Lot Number: C24536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2016
• Initial Report FDA Received Date: 09/23/2016
• Patient Sequence Number: 1