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

Catalog Number CPL10020630

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product is expected to be returned for analysis, however it has not been received.Additional information will be submitted within 30 days of receipt.

Event Description

It was reported by a healthcare professional that a deltaplush coil (cpl10020630/c26421) could not be detached during a procedure.Another one was used to complete the procedure.There was no report of patient injury.

Manufacturer Narrative

This final mdr will be the only report submitted for mfr report #3013875781-2017-00006.Conclusion: based on the information, the event could not be confirmed.The product was not returned for analysis; however 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.There were no significant safety signals identified related to the reported event based on a review of complaint history for the device.Therefore, no corrective actions will be taken at this time.

Manufacturer Narrative

This follow-up mdr is the only report being submitted for mfr report #3013875781-2017-00006.(b)(6).

Manufacturer Narrative

This follow-up mdr will be the only report submitted for mfr report #3013875781-2017-00006.This mdr is being submitted to report the following additional information received on january 03, 2018: there was no damage noted to the coil, coil delivery system, or coil detachment system prior to the procedure.An enpower dcb and connecting cable were used during the procedure, both lot numbers are unknown.A pre-deployment electrical check was performed and a low battery light was not observed during the case.The green system ready light illuminated.All connections appear to fit properly without the application of excessive force.The same enpower dcb and connecting cable were used successfully with subsequent coils.The event did not result in a procedural delay.

• Brand Name: DELTAPLUSH - CERECYTE MICROCOIL
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle jura ; SZ
• Manufacturer Contact: joaquin kurz ; 47709 freemont blvd; freemont, CA 94538 ; 9497899383
• MDR Report Key: 6954355
• MDR Text Key: 90461329
• Report Number: 3013875781-2017-00006
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528008231
• UDI-Public: (01)00878528008231(17)190430(10)C26421
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K083646
• 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,Followup,Followup
• Report Date: 09/20/2017

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: 04/30/2019
• Device Catalogue Number: CPL10020630
• Device Lot Number: C26421
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2017
• Initial Date FDA Received: 10/17/2017
• Supplement Dates Manufacturer Received: 12/07/2017; 01/03/2018; 01/10/2018
• Supplement Dates FDA Received: 01/02/2018; 01/07/2018; 01/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1