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

Catalog Number	DFS10020220
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Procode: krd/hcg.The device was returned for analysis; however, the analysis has not been completed.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, during coiling of a basilar aneurysm, a deltapaq coil (dfs10020220/c13011) failed to detach using a detachment control box (dcb00000500/lot unk) and a cable (ecb00018200, lot unk).The coil was the second coil used.After successful positioning in the aneurysm the coil could not be detached after several attempts.The coil was recovered without detachment.A pre-deployment electrical check had been performed and no fault light was seen during the case.Upon pressing the power button, all lights illuminated.All connections appeared to fit properly witout application of excessive force.The next coil could be placed successfully with the sl 10 microcatheter using the same detachment control box and cable.The cable and detachment box were discarded after the procedure.There was no patient harm or surgical delay greater than 30 minutes reported.It was reported that the device would be returned for analysis.
Additional Manufacturer Narrative
Conclusion: as reported by a healthcare professional, during coiling of a basilar aneurysm, a deltapaq coil (dfs10020220/c13011) failed to detach using a detachment control box (dcb00000500/lot unk) and a cable (ecb00018200, lot unk).The coil was the second coil used.After successful positioning in the aneurysm the coil could not be detached after several attempts.The coil was recovered without detachment.A pre-deployment electrical check had been performed and no fault light was seen during the case.Upon pressing the power button, all lights illuminated.All connections appeared to fit properly without application of excessive force.The next coil could be placed successfully with the sl 10 microcatheter using the same detachment control box and cable.The cable and detachment box were discarded after the procedure.There was no patient harm or surgical delay greater than 30 minutes reported.The device was returned outside its original packing hoop and was wrapped in a hooped fashion upon return.The entire length of the introducer sheath was rezipped over the dpu as seen by the resheathing tool retracted back to the clear tab at the proximal end of the translucent portion of the introducer sheath.The distal end of the dpu was seen through the translucent introducer sheath without the embolic coil.The dpu was then advanced outside the introducer sheath to obtain a clear view of the distal end.The view of the distal end outside the introducer sheath confirms the embolic coil was not attached to the distal end of the dpu.The detachment fiber and resistive heating coil showed evidence of melting.No visual damages to the device were observed.The resistance was tested and registered a reading of 53.4 ohms, which is within specification of 48.5 - 56.0 ohms.No detachment was attempted as the embolic coil was already shown to be detached from the dpu.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.The complaint of the coil not being able to be detached was not confirmed.The coil was returned with the embolic coil detached from the delivery system and the detachment fiber and resistive heating coil appeared to have melted as designed.The evidence indicates the coil was successfully detached.This detachment must have occurred during post-procedure handling since there was no report of detachment during the procedure and it was reported that the device was removed from the microcatheter.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.

• Brand Name: DELTAPAQ - PLATINUM MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6588028
• Report Number: 2954740-2017-00113
• Device Sequence Number: 719531
• Product Code: HCG
• UDI-Device Identifier: 00878528007562
• UDI-Public: (01)00878528007562(17)170930(10)C13011
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K080379
• 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): 05/03/2017

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: 09/30/2017
• Device Catalogue Number: DFS10020220
• Device Lot Number: C13011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Initial Date Received by Manufacturer: 05/04/2017
• Supplement Date Received by Manufacturer: 07/05/2017
• Initial Report FDA Received Date: 05/24/2017
• Supplement Report FDA Received Date: 07/05/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SL-10 CATHETER
• Patient Age: 42 YR