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

Catalog Number PC418164730

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2017

Event Type  malfunction  

Manufacturer Narrative

This is initial mdr report being submitted with associated mfr# 2954740-2017-00065 and 2954740-2017-00064.(b)(4).Concomitant medical products: sheath introducer (6fr flexor, cook inc); guidewire (0.035inch radifocus, terumo); micro catheter (prowler select plus); enpower.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

As reported by a healthcare professional, during the procedure two coils a presidio 18 cere 16mm x 47cm and a presidio 18 cere 18mm x 46 cm failed to re-sheath.The procedure was coil embolization of an aneurysm at the left subclavian with bypass.The patient was a (b)(6) male whose vessel was heavily torturous and not calcified.The presidio 18 coil (pc4181846-30, c34513) was inserted into the prowler microcatheter (lot unknown).The coil did not fit properly even though the physician tried it several times; the coil was not winding well.The physician attempted to re-sheath the coil, however the zipper split and was unable to re-sheath the coil.The coil was the replaced with another presidio 18 coil (pc4181647-30, c40180).The coil was inserted into the micro catheter.This coil also did not fit properly and the physician judged the coil was not placed in lesion.The physician tried to re-sheath the coil but the sheath introducer split open when the delivery wire was withdrawn and was unable to re-sheath the coil.Since the blood flow was also strong, an amplatzer vascular plug was placed in the proximal portion of the subclavian artery.The flow still remained, the micro catheter was approached again and added about 4 coils.The procedure was successfully completed without further issues.However, due to the event it was delayed by 30 minutes.There was also no patient injury / complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and a constant flush was 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 products will be returned for the investigation.No further information is available.

Manufacturer Narrative

This is final mdr report being submitted with associated mfr# 2954740-2017-00065 and 2954740-2017-00064.Limited information was received.The prowler select plus microcatheter and the rotating hemostatic valve (rhv) were not returned.All location and measurement callouts are approximate and for reference only.As viewed through the returned packaging, unreported coil, sheath, and device positioning (dpu) entanglement and coil stretching were found.The exposed coil was retracted into the resheathing tool outside the sheath.Unreported stretching damage found both at the proximal end and at the middle section of the coil.The remainder of the coil is undamaged.No protrusion site or sheath damage was found.No manufacturing defects were found.At least a portion of the unreported damage occurred due to post-procedural handling, therefore the circumstances of how and when all the damage occurred to the unit cannot be determined as it was stated in the complaints that, ¿¿no visible defect/damage was noted on the products prior to (and after) the event¿¿.The positioning difficulty of the coil at the target site cannot be confirmed.It was reported in the complaint that, ¿¿no visible defect/damage was noted on the products prior to (and after) the event¿¿ and due to unreported coil damage, without the aneurysm dimensions, without the list of coils already dwelling inside the target site, and the return of the microcatheter, the root cause of the positioning difficulty cannot be determined.In addition, without the return of the prowler select plus microcatheter and the rotating hemostatic valve (rhv) used in the procedure, it cannot be determined if these components contributed to the complaint event.The complaint of the resheathing difficulty is confirmed.No protrusion site or sheath damage was found, therefore the root cause of the resheathing difficulty cannot be determined, however the most likely contributing factor appears to be handling by the end user.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 positioning difficulty cannot be confirmed.The root cause of the failure could not be determined due to additional unreported damage to the coil and without return of concomitant products it cannot be determined if those components had any additional contributions to the complaint event.The reported event of resheathing difficulty was confirmed.The root cause of the resheathing difficulty cannot be determined, however the most likely contributing factor appears to be handling by the end user.A 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: PRESIDIO 18 - 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: 6439206
• MDR Text Key: 71054526
• Report Number: 2954740-2017-00065
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528003281
• UDI-Public: (01)00878528003281(17)201231(10)C40180
• 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,Followup
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: PC418164730
• Device Lot Number: C40180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 46 YR