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

Catalog Number CDF10051530

Device Problem Delivery System Failure (2905)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2016

Event Type  malfunction  

Manufacturer Narrative

This is one of one initial mdr report being submitted for this complaint.(b)(4).Concomitant medical products: excelsior 1018 (stryker) microcathter; enpower dcb / cable (lots unknown); presidio 18 (8mm x 30cm) coil; 2 deltapaq (5mm x 15cm)coil.The product is available 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.

Event Description

It was reported by the hospital contact that after a presidio 18 (8mm x 30cm, as the anchoring coil) and a deltapaq (5mm x 15cm) were successfully implanted into the target vessel, the complaint deltapaq (cdf100515-30/c17486) was chosen next.Although the electrical check prior to the insertion was successful, when the deltapaq was delivered to the target site and re-connected to the cable to detach, the green system ready light did not illuminate.During the delivery of the deltapaq, the microcatheter got migrated out from the target site, due to the fact that the site was almost fully packed to steadily position the microcatheter tip, and the physician had to repeat withdrawing and forwarding the deltapaq to place it to the site, yet apart from this there was not any other issue during the delivery.Another deltapaq (5mm x 15cm) was inserted instead, and was successfully implanted into the target site.The procedure was completed without further issues or delay.There were no patient injury/complications.The complaint product was 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 damage was noted on the product prior to or after the event.The complained product will be returned for analysis.No further information is available.The procedure was the coil embolization of the rt-internal iliac artery prior to the endovascular aneurysm repair due to the rupture of the aneurysm at the rt-common iliac artery.The patient was a male of unknown dob, whose vessels were moderately torturous but not calcified.An excelsior 1018 (stryker) and enpower dcb / cable (lots unknown) were used for this procedure.All connections appeared to fit properly without application of excessive force.

Manufacturer Narrative

This is one of one final mdr report being submitted for this complaint.Very limited information was received.The unspecified enpower and connecting cable were not returned.The excelsior 1018 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.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.As viewed through the returned packaging, it was found that the coil was entangled which was unreported.Further examination found unreported damage that the coil was damaged.Located 4 millimeters off the distal tip of the device positioning unit (dpu) is a section of unreported compression and buckling damage.The detachment fiber did not receive heat and melt.Note the unreported compression and buckling damage at the proximal end of the coil.The proximal end of the coil has unreported kinking damage.The mid-section of the coil is undamaged.The distal section has unreported kinking damage.The first secondary loop has unreported damage of being bent up and angled away from the remaining coils.The device positioning unit (dpu) passed electrical testing with resistance at 51.6 ohms (range 48.5/56.0) and the sample enpower and cable systems ready green light illuminated.The coil detached on the first detachment cycle.Post-detachment electrical testing found that the enpower systems ready green light remained illuminated and the resistance still passed at 51.6 ohms.Post-detachment inspection found that the detachment fiber received heat and melted as designed.Due to post-procedural cleaning, handling, and packaging, the circumstances of how and when all the unreported damage contained in this report occurred cannot be exactly determined.No manufacturing defects were found.The complaint of the systems ready green light not illuminating is not confirmed.The dpu passed all electrical testing and the coil was detached on the first detachment cycle with the systems ready green light remaining illuminating during all testing, therefore the root cause of the systems ready green light not illuminating during detachment cannot be determined.In addition, without the return of the complaint detachment system (dcb/cable) and the excelsior 1018 microcatheter used in the procedure, it cannot be determined if these components contributed to the complaint event.The following damage found to the unit matches the report that the target site was almost fully packed which explains the severely buckled dpu located 4 millimeters off the distal tip of the dpu, the compression and buckling coil damage, and the first secondary winding off the ball tip that was bent up and angled away from the remaining coils.This also explains the microcatheter migrating away from the target site.Some of the damage and issues occurring during the procedure may, in part, be related to the selection of the non-compatible 18 series microcatheter that was utilized with a 10 series microcoil system.For optimum product performance and to prevent potential complications, the instructions for use (ifu) recommends, ¿proper selection of the appropriately sized microcatheter is required to avoid damage to the codman microcoil system and to minimize potential complications.Microcatheter selection is also determined by the physician and is predicated by the location of the aneurysm, patient safety, and physician preference.The codman microcoil 10 system is compatible with microcatheters with inner lumen diameters ranging from 0.014 to 0.017 in (0.356 to 0.432 mm).The inner lumen of the excelsior 1018 microcatheter is 0.019¿.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 systems ready green light not illuminating is not confirmed.The dpu passed all electrical testing and the coil was detached on the first detachment cycle with the systems ready green light remaining illuminating during all testing, therefore the root cause of the systems ready green light not illuminating during detachment cannot be determined.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.

• Brand Name: DELTAPAQ - CERECYTE MICROCOIL
• Type of Device: CNV DCS COILS
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• Manufacturer Contact: karen anigbo ; 821 fox lane; san jose, CA 95131 ; 5088288374
• MDR Report Key: 5729508
• MDR Text Key: 47532409
• Report Number: 2954740-2016-00127
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K080437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2018
• Device Catalogue Number: CDF10051530
• Device Lot Number: C17486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1