MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL HELIPAQ 10 - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CHE10102030
Medical Device Problem Codes	Kinked (1339); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint met mdr reporting criteria on 9/6/2017 when analysis revealed the coil was kinked.Conclusion: the device was returned in its packaging hoop.The device was removed from the hoop.The resheathing tool appeared fractured and separated.A dual kink was present approximately 152.5 cm from the proximal end of the device.There were copious amounts of dried blood within the introducer sheath tubing.The device positioning unit (dpu) core wire protruded from the introducer sheath immediately distal to the resheathing tool.The embolic coil appeared kinked and was not straight through the translucent introducer sheath.There was a mass of dried blood at the distal end of the embolic coil.The fracture of the resheathing tool appeared to occur when the tool was positioned near the marker band on the dpu.The fracture appears ductile in nature.The v notch of the resheathing tool was elevated above the surface plane.The v notch surface can be raised if the locking mechanism becomes caught and the sheath is retracted straight back instead of up and at a 45 degree angle from the resheathing tool.This may have caused the resheathing tool to separate if the distal end was held in place as the sheath was retracted.The issue that the device could not be advanced through the microcatheter was confirmed and is likely caused by two factors acting separately or in tandem.Due to the fracture of the resheathing tool, the device cannot be unsheathed properly causing the core wire to protrude from the introducer.In this condition the wire cannot advance through the introducer without resistance.The dried blood also indicates that the device was not adequately flushed, causing the blood to pool in the introducer sheath.The ifu (208535-001) states that if unusual friction is noticed during advancement or retraction of the microcoil system through the introducer to flush the y-connector and verify that fluid exits the slit in the clear portion of the introducer.If friction is still noticed during advancement and retraction verify flush lines are open and properly pressurized.The kink on the device can also be caused when the device is advanced against the blood pooling in the introducer.The kinks did not occur during manufacturing as review of the device history record confirmed there were no kinks on the device.There is no current safety signal identified related to the reported events based on reviews of complaint histories for the device.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.This is an initial/final mdr report.
Event or Problem Description
As reported by a healthcare professional, during aneurysm coil embolization, they tried to insert the helipaq (che10102030/ c28384) coil, but it did not pass through the unspecified microcatheter despite several attempts and during analysis it was found that the coil was kinked.There were no patient adverse events, but the procedure was delay 15 minutes.The procedure was completed with a similar product.It was reported that the device would be returned for analysis.

• Brand Name: HELIPAQ 10 - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6847319
• Report Number: 2954740-2017-00251
• Device Sequence Number: 1117349
• Product Code: HCG
• UDI-Device Identifier: 00878528000624
• UDI-Public: (01)00878528000624(17)190630(10)C28384
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: K022420
• 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): 06/08/2017

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: 06/30/2019
• Device Catalogue Number: CHE10102030
• Device Lot Number: C28384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 09/06/2017
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 59