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

Catalog Number CDF10020430

Device Problems Kinked (1339); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2017

Event Type  malfunction  

Manufacturer Narrative

This event was reported to codman cnv on (b)(6) 2017; however, did not meet mdr reporting criteria until 05/11/2017 when the analysis was completed.Conclusion: the deltapaq was returned for analysis.As seen through the returned packaging, the coil was found to be entangled around the dpu.The proximal end of the resistive heating coil section has been severely buckled (unreported).The proximal end of the coil had two compression and buckling sections of damage (unreported).No manufacturing defects were found.Due to post-procedural handling, cleaning, and packaging, it cannot be determined when and how all the unreported damages to the coil and dpu found occurred.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 coils resistance in the headway microcatheter could not be confirmed.Without the return of the headway microcatheter and due to post-procedural handling, cleaning, packaging which may have produced further if not all damages found to the dpu and coil, the root cause of the coils resistance inside the microcatheter cannot be determined; however, the evidence suggests interference from an unknown source and location may have contributed to the event.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.This is an initial/final mdr report.This is 1 of 3 mdrs being submitted for this complaint, with associated report numbers of 2954740-2017-00105, 2954740-2017-00104 and 2954740-2017-00103.

Event Description

As reported by a healthcare professional, a physician felt strong resistance during advanced a deltaplush (cpl10015330/ c40127), a deltapaq (cdf10020430/ c33041) and a presidio (pc410073030/ c41431) through a headway 17 microcatheter.Upon return of the devices for analysis, the deltaplush and deltapaq coils were found to be compressed and buckled and the presidio coil was stretched.Other coils were able to be advanced.The physician replaced the coils with same like products and the procedure was successfully completed.There were no potential adverse events.After multiple attempts to obtain additional information, no additional information was provided.

• Brand Name: DELTAPAQ - 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: 6559782
• MDR Text Key: 74949647
• Report Number: 2954740-2017-00104
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528007081
• UDI-Public: (01)00878528007081(17)200131(10)C33041
• Combination Product (y/n): N
• Reporter Country Code: KN
• 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
• Report Date: 02/14/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: CDF10020430
• Device Lot Number: C33041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2017
• Initial Date FDA Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HEADWAY 17 MICROCATHETER