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

Catalog Number	CDX18062530
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is initial mdr report being submitted for this complaint with associated mfr# 2954740-2017-00066.Additional procode: krd.(b)(4).The product will not be returned for analysis however a device history record review is currently being conducted and the results are not yet available.No conclusion is made at this time.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
It was reported by a healthcare professional that during the procedure an orbit galaxy complex fill coil failed to resheath and resistance was experienced when using a deltamaxx coil which also unraveled.The procedure was the gastroduodenal artery aneurysm coil embolization.The patient was a (b)(6) male whose vessel was moderately torturous and not calcified.The og cmplx fill (complaint product1) was attempted to use for embolization of the gda-an outflow artery.However, it was a smaller size for the lesion so the physician tried to re-sheath the coil.But the orange-colored zipper did not slide and the coil was unable to be re-sheathed.The coil was replaced with another one.A deltamaxx (complaint product2) coil was inserted into the micro catheter but there was strong resistance felt at the middle portion of the catheter, so the coil was withdrawn, it was found that the coil unraveled.The coil was replaced with another one.The procedure was successfully completed without further issues or delay.There was also no patient injury / complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and a constant flush was maintained at all times.No visible defect/damage was noted on the products prior to (and after) the event.No unintended detachment was observed in the vessel or in the microcatheter.The products are not available for investigation.No further information is available.
Additional Manufacturer Narrative
This is final mdr report being submitted for this complaint with associated mfr# 2954740-2017-00066.The deltamaxx will not be returned, therefore the root cause of the coils resistance and its stretching cannot be determined.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 action will be taken at this time.

• Brand Name: DELTAMAXX - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6449073
• Report Number: 2954740-2017-00066
• Device Sequence Number: 621847
• Product Code: HCG
• UDI-Device Identifier: 10878528008573
• UDI-Public: (01)10878528008573(17)210228(10)C41848
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/07/2017

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: 02/28/2021
• Device Catalogue Number: CDX18062530
• Device Lot Number: C41848
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2017
• Supplement Report FDA Received Date: 04/04/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICRO CATHETER (CARRY LEON, UTM)
• Patient Age: 74 YR