MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPLUSH - CERECYTE MICROCOIL; CNV DCS COILS

Catalog Number CPL10015330

Device Problems Sticking (1597); Failure to Disconnect (2541)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/07/2015

Event Type  malfunction  

Manufacturer Narrative

The product has been forwarded to codman 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.(b)(4).

Event Description

The contact from the facility reported that during a procedure to embolize aneurysms at the basilar artery, inferior mesenteric artery, and intercostal artery, a deltapaq coil (cdf100208-30 / c35231) got stuck at the distal end of the microcatheter and another deltapaq coil (cdf100310-30 / c28349) could not be resheathed.It was also reported that a deltaplush coil (cpl100153-30 / c15193) could not detach.The tortuosity and calcification levels of the vessels were not available.An excelsior microcatheter (stryker, type unknown) and enpower dcb / cable (lots unknown) were used for this procedure.It was reported that the first complaint deltapaq (c35231) got stuck at the distal end of the microcatheter.The physician tried to push the coil out from the microcatheter tip several times, but was unable to advance the coil out.Thrombus in the microcatheter was suspected, and a guidewire was inserted through the microcatheter to re-insert the coil, but to no avail.Eventually the use of the deltapaq (c35231) was abandoned, and it was withdrawn from the patient.The device did not kink or bend at any time.The microcatheter did not need to be removed.Furthermore, it was also reported that the second complaint deltapaq (c28349) could not be re-sheathed because the distal end of the introducer sheath was split open.The damage was not noted when the coil was inserted.The coil was re-sheathed because, although the delivery was successful, the microcoil was the wrong size for the target site.It was also reported that the complaint deltaplush (c15193) could not be detached when the detach button was pressed, despite the detachment light illuminating during the detachment cycle and the signal beeping.The detach button was pressed many times, but to no avail.All connections appeared to fit properly without use of excessive force.The same connecting cable and dcb were used successfully with subsequent coils.The coil was replaced with a new one to continue.The procedure was then successfully completed without further issues, and there were no patient injuries / complications.The information of whether there was a procedural delay or not was unavailable.The complaint products were new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all times.No visible damages were noted on the products prior to the events.Other than the introducer sheath damage on deltaplush lot# c28349 there were no visible damages to the devices after use.There was no unintended detachment of the microcoils observed neither in the microcatheter nor in the vessel.All the microcoils were still attached to their delivery systems when removed from the patient.The complained products will be returned for analysis.No further information is available.

Manufacturer Narrative

The unspecified enpower detachment control box and the unknown connecting cable were not returned or identified.The unidentified stryker microcatheter was not returned.Concerning cleanliness only, the microcoil system was returned in almost pristine condition.The system was either not used or was cleaned/rinsed 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.Any trace evidence that may have been complaint related may have been altered or removed prior to being returned.As viewed through the returned packaging, it was found that unreported damage of the coil was unsheathed, entangled, and knotted, and severely damaged around the device positioning unit (dpu) was found.Due to post-procedural cleaning, handling, and packaging the circumstances of how and when this damage occurred cannot be determined.The detachment fiber is undamaged, intact, and did not receive heat and melt.The coil¿s socket ring was pushed down inside the outer sheath and against the resistance heating coil.The dpu failed electrical testing with resistance at 0.0 ohms (range 48.5/56.0) (mps-prp0243) and the enpower systems ready green light failed to illuminate (ifu).Compression of the resistive heating coil section caused the dpu to pass electrical testing with resistance at 52.0 ohms and the enpower systems ready green light illuminated.No manufacturing defects were found.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.The complaint of the coil¿s non-detachment inside the target site is confirmed.The returned dpu failed electrical testing.While the exact root cause cannot be determined, the most likely contributing factor may have been a fracture of the solder joint connection inside the resistive heating coil which prevented the coils detachment.The circumstances of how and when this damage occurred cannot be determined as all microcoil systems are electrically tested prior to final packaging.In addition, without the return of the complete detachment system and without the identification or return of the stryker microcatheter used in the procedure, it cannot be determined if these components had any additional contributions to the complaint 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.

• Brand Name: DELTAPLUSH - CERECYTE MICROCOIL
• Type of Device: CNV DCS COILS
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• Manufacturer Contact: kimberly soter ; 821 fox lane; san jose, CA 95131 ; 5088288310
• MDR Report Key: 5405526
• MDR Text Key: 38228454
• Report Number: 2954740-2016-00035
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/14/2018
• Device Catalogue Number: CPL10015330
• Device Lot Number: C15193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2016
• Date Device Manufactured: 02/15/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1