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

Catalog Number PC410041230

Device Problems Knotted (1340); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2016

Event Type  malfunction  

Manufacturer Narrative

This is one of one initial/final mdr report submitted for this complaint with associated mfr# 2954740-2016-00273.This event became mdr reportable on 14nov2016 upon investigation of product.(b)(4).Concomitant product(s): sheath introducer (medikit); guide wire (gtwire, terumo); guiding catheter (jr, terumo); micro catheter (headway, terumo); enpower.Very limited information was received.The headway microcatheter and the rotating hemostatic valve (rhv) were 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 viewed through the returned packaging, unreported damage of coil knotting at the distal tip of the green introducer and coil stretching was found.Unreported damage located 33.0 centimeters off the proximal end as the device positioning unit (dpu) has been found to have been bent.Microscopic view of the knotted coil and more unreported coil stretching.Note that proximal to the anchored knot the remainder of the coil has been stretched.No manufacturing defects were found.Due to the severe and unreported damage found to the coil no duplication of the field complaint could be performed in the laboratory.The circumstances of how and when the unreported damage occurred to the device occurred cannot be determined as it was stated in the complaint that, ".No visible defect/damage was noted on the products prior to and after the event." the complaint of the coils advancement difficulty inside the microcatheter cannot be confirmed.Due to the severe and unreported damage found to the coil, the exact root cause cannot be determined; however the evidence suggests that distal interference of an unknown source and location may have interfered with the coils advancement inside the microcatheter.In addition, without the return of the headway microcatheter and the rhv used in the procedure, it cannot be determined if these components 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.Since there was no evidence of a manufacturing issue related to the event, no corrective action will be taken at this time.

Event Description

As reported by a health care professional, during the procedure resistance was experienced with the competitors microcatheter when using a presidio coil (pc410041230/c37677).The procedure was the coil embolization for the balloon-occluded retrograde transvenous obliteration for a porto pulmonary venous anastomosis.The patient was a (b)(6) year-old female whose vessels were moderately torturous and mildly calcified.The micro catheter was approached to the target lesion which was pre- brto developed at the collateral pathway.The coil embolization was performed without the y connector and the continuance flow.A presidio coil 4*11.5 (lot unknown) was inserted as 1st coil for anchoring.After which the complaint presidio was inserted into the micro catheter but the delivery wire could not be advanced at the middle of the catheter.Therefore the coil was retrieved once and the micro catheter was flushed.The coil was reinserted into the catheter but it got stuck at the same portion.The coil was retrieved again.Then a micro wire (14) was passed through the micro catheter without any problem.When coil was reinserted into the catheter, it got stuck.The coil was replaced with another coil (4*15 delatamaxx) and the coil was used with the same micro catheter.There was no resistance felt and the coil could be placed in the target lesion.The procedure was successfully completed without further issues or delay.There were no patient injuries or complications reported.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 defect/damage was noted on the products prior to and after the event.No unintended detachment was observed in the vessel or in the microcatheter.The product will be returned for the investigation.No further information is available.".

• Brand Name: PRESIDIO 10 - CERECYTE MICROCOIL
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• 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: 6104923
• MDR Text Key: 59976606
• Report Number: 2954740-2016-00273
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528003007
• UDI-Public: (01)00878528003007(17)200831(10)C37677
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082739
• 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
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: PC410041230
• Device Lot Number: C37677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR