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

Catalog Number	CDX18052030
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is initial mdr report being submitted with associated mfr# 2954740-2017-00110.Additional procode: krd.(b)(4).Guidewire (radifocus, terumo); micro catheter (sl10, stryker); y connector (okay, goodman); enpower cable (unknown lot).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 a healthcare professional, during the procedure a deltamaxx coil ((b)(4)) unraveled and two trufill dcs syringes ii ((b)(4)) were unable to create pressure.The procedure was the coil embolization of an aneurysm for arteriovenous fistula at the left pulmonary arteriovenous.The patient¿s vessel was heavily torturous and mildly calcified.The deltamaxx coil (complaint product1) was the first coil used as an anchor, the coil unraveled and the coil came off outside the body during removal of the coil.The coil was replaced with another one (same size) and the procedure was continued.When purging, the pressure of galaxy coil did not increase with the trufill syringe (complain product2).The syringe was replaced with a new trufill dcs syringe ii (complaint product3) but the same issue occurred.The syringe 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 the constant flush had been maintained at all time.The products will be returned for the investigation.No further information is available.
Additional Manufacturer Narrative
This is final mdr report being submitted with associated mfr# 2954740-2017-00110.Concerning cleanliness only, the microcoil system was returned in almost pristine condition.The system was either not used or was cleaned by the end user/hospital 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.As viewed through the returned packaging, a detached coil was found.Except for a kink at one section, the remainder of the coil is undamaged and no stretching was found.The resistive heating coil¿s outer sheath has been completely melted.This can only occur outside the patient and in an air environment.No manufacturing defects were found.The circumstances of how and when the coil was electro-mechanically detached by the enpower dcb cannot be determined.The complaint of the coil stretching is not confirmed.No coil stretching was found as only a kinked section was found; therefore, the root cause of the coil stretching cannot be determined.The complaint of the coil coming off during removal is confirmed.The enpower detachment button was pressed while the coil was outside the patient as only an air detachment can cause this type of damage, therefore the root cause of the coil¿s detachment was due to the end user pressing the detachment button.The circumstances of how and when this occurred 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.Based on the information and analysis, the event was not confirmed.No stretching was found on the returned device; therefore, the root cause of the coil 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 actions 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: 6574897
• Report Number: 2954740-2017-00110
• Device Sequence Number: 10937448
• Product Code: HCG
• UDI-Device Identifier: 10878528008566
• UDI-Public: (01)10878528008566(17)200930(10)C37568
• 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): 04/27/2017

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: 09/30/2020
• Device Catalogue Number: CDX18052030
• Device Lot Number: C37568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2017
• Supplement Report FDA Received Date: 05/31/2017
• Patient Sequence Number: 1