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

Catalog Number	DPL10020420
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The deltaplush will not be returned, therefore the root cause of the premature detachment and stretching cannot be determined.Dhr: 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, the event could not be confirmed.The product was not returned for analysis; however 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.Common device name protocode: krd/hcg.
Event or Problem Description
The contact from the facility reported that deltaplush coil (dpl10020420/p11075) stretched and was separated in the microcatheter when it was withdrawn.The aneurysm was saccular and the size of the aneurysm is unknown.The physician placed the first coil (cashmere, details unknown) without any problems.Then he wanted to place the deltaplush coil.The coil reached the aneurysm but the physician wanted to change its position, so he removed it from the aneurysm into the microcatheter (excelsior sl10, details unknown.) when he pulled it back into the microcatheter the deltaplush coil was stretched and then snap off in the microcatheter.The physician had to remove the entire microcatheter with the snapped coil.After that event he placed a new microcatheter in the aneurysm and continued the procedure.No significant delay greater 30 minutes reported nor consequences for the patient.An adequate continuous flush was maintained at all times.There was no resistance between the guidewire and microcatheter when accessing the target site.There was no resistance at any time during advancement of the coil through the microcatheter.One other coil (details unknown) went through the same microcatheter without resistance.There were no kinks in the microcatheter that could have contributed to the event.

• Brand Name: DELTAPLUSH - PLATINUM MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6382981
• Report Number: 2954740-2017-00045
• Device Sequence Number: 528418
• Product Code: KRD
• UDI-Device Identifier: 00878528008064
• UDI-Public: (01)00878528008064(17)200831(10)P11075
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K083646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/06/2017

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: Other
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: DPL10020420
• Device Lot Number: P11075
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2017
• Initial Report FDA Received Date: 03/06/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SL-10
• Patient Age: 68 YR