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

Catalog Number CDF10015230

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2017

Event Type  malfunction  

Manufacturer Narrative

This initial mdr will be the only report submitted for mfr #2954740-2017-00187.Udi: (b)(4).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.

Event Description

It was reported by a healthcare professional that a deltapaq coil (cdf10015230/c40841) was used during a coil embolization procedure of an aneurysm in the posterior communicating artery, 2.2x3.8mm in size, and could not be detached.The coil was withdrawn and a new coil was used to complete the procedure.The patient was a (b)(6) -year-old female.There was no report of patient injury.

Manufacturer Narrative

This final mdr will be the only report submitted for mfr report #2954740-2017-00187.The device was returned with its inner pouch.There were no visible damages found on the device.The resheathing tool was positioned near the proximal end of the introducer sheath.A small section of the embolic coil was advanced outside the green introducer sheath.The coil was advanced out of the green introducer and there was no visible damage to the coil.The device¿s resistance was 52.3 ohms when tested with a multimeter which is within the specification.The device was connected to a connecting cable and a detachment control box.The system ready light illuminated on the detachment control box.On the detachment cycle the detach light illuminated and the audible beep was heard.The coil detached with no problem.The complaint that the coil could not be detached was not confirmed.The device passed resistance testing and the coil detached without any problem.There were no issues found in the dhr related to the reported complaint.

• 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: 6669190
• MDR Text Key: 78547520
• Report Number: 2954740-2017-00187
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528007012
• UDI-Public: (01)00878528007012(17)210131(10)C40841
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: CDF10015230
• Device Lot Number: C40841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR