MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL HELIPAQ 18 - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CHE18073030
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of one initial/final report being submitted for this complaint with associated mfr# 2954740-2016-00318.(b)(4).Limited information was received.The coil was not returned.Concerning cleanliness only, the microcoil system was returned in almost pristine condition.The system was either not used or was cleaned 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 observed through the returned packaging, unreported damage of the coil being detached from the device positioning unit (dpu) was found.The coil was mechanically detached.The circumstances of how and when the coil was detached and not returned cannot be determined.Located on the top proximal end of the re-sheathing tool in the open cutout section, the v notch has been fractured with a portion of the sheath protruding through the fracture.The locking mechanism has compression and stretching damage.No manufacturing defects were found.The complaint of the sheath damage is confirmed.The most likely root cause of the sheath damage may have occurred when the microcoil system was first unlocked for use and the sheath was retracted straight back instead of up at a forty-five degree angle and then back.When the sheath was pulled straight back, the locking mechanism caught the inside of the v notch of the resheathing tool and became embedded.In addition, the locking mechanism may not have been fully disengaged off the core wire.The sheath also caught the v notches extended edges.This produced a binding action between the device positioning unit (dpu), the sheath, and the coil.This binding action produced significant resistance which produced sheath damage.For optimum product performance and to prevent potential complications, the instructions for use (ifu) recommends, ¿hold the introducer sheath (loosely-looped) in the left hand.Keeping the introducer tip near the re-sheathing tool, grasp the distal end of the re-sheathing tool between your left thumb and forefinger.Grasp the clear tab near the end of the introducer sheath body with the thumb and forefinger of your other hand.Gently pull the clear tab of the introducer sheath out and away from the re sheathing tool at a 45-degree angle to unlock the microcoil.Continue to pull the tab until an additional 0.5 to 1.0 inches (1.3 to 2.5 cm) of the translucent material is exposed.Gently fold the translucent tab towards the distal end, and firmly grasp the distal end of the re sheathing tool and the translucent tab between your thumb and forefinger, as shown in figure 3¿¿ caution: if unusual friction is noticed during advancement or retraction of the microcoil system, verify the locking mechanism, or clear tab is unlocked and pulled out from the resheathing tool approximately 1in.(2-3cm).¿ in addition, without the return of the detached coil it cannot be determined if this component had any additional contributions to the complaint event.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 the analysis, the reported event of sheath damage was confirmed.Without return of concomitant products it cannot be determined if those components had any additional contributions to the complaint event.Although a definitive conclusion cannot be made, based on the analysis, it appears that procedural factors related to the unsheathing process possibly contributed to the event.Additionally, review of 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.
Event or Problem Description
It was reported by a health care professional that during an intervention the surgeon recognized the white sheath of a helipaq cere 7mm x 30 cm coil (che18073030/c14002)to be defective, it was torn.The coil introducer sheath was found to be split open.The product issue was discovered before it was used on the patient.The procedure was completed with a same like product.No significant delay or patient harm reported.There were no intra or post procedural complications related to device or reported event.There were no other issues reported with the product.It was initially reported that the complaint device is available for return.

• Brand Name: HELIPAQ 18 - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6181283
• Report Number: 2954740-2016-00318
• Device Sequence Number: 18976613
• Product Code: HCG
• UDI-Device Identifier: 00878528000778
• UDI-Public: (01)00878528000778(17)171102(10)C14002
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082739
• 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): 11/24/2016

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: 11/02/2017
• Device Catalogue Number: CHE18073030
• Device Lot Number: C14002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2016
• Initial Report FDA Received Date: 12/16/2016
• Patient Sequence Number: 1