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

Catalog Number CDF10051530

Device Problems Difficult To Position (1467); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device was returned for analysis; however, the analysis has not yet been completed.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a healthcare professional, during the procedure, the deltapaq coil (cdf10051530/ c39413) could not be inserted into the aneurysm due to positioning difficulty and stretched.They withdrew the coil without difficulty, and used a new coil to complete the procedure.There had been no resistance between the deltapaq and the microcatheter, and a continuous flush had been maintained through the microcatheter.Aneurysm characteristics and size were unavailable.There was no report of patient injury or procedure delay.It was reported that the device would be returned for analysis.

Manufacturer Narrative

As reported by a healthcare professional, during the procedure, the deltapaq coil (cdf10051530/ c39413) could not be inserted into the aneurysm due to positioning difficulty and stretched.They withdrew the coil without difficulty, and used a new coil to complete the procedure.There had been no resistance between the deltapaq and the microcatheter, and a continuous flush had been maintained through the microcatheter.Aneurysm characteristics and size were unavailable.There was no report of patient injury or procedure delay.It was reported that the device would be returned for analysis.The device was returned in the packaging hoop within the opened inner pouch.The device could not be removed from the introducer hoop; therefore, the hoop was dissected and the device positioning unit (dpu) core wire along with the hub of the device and the embolic coil were separated from its introducer sheath.There were no damages observed on the dpu core wire.No damages were found on the embolic coil and the ball tip is intact at the distal end of the coil.The coil did not appear stretched.The complaint that the coil stretched and was difficult to position was not confirmed.There were no damages or stretches found on the dpu or embolic coil that could cause the issues.As the introducer sheath was removed from the rest of the unit, the user would not be able to resheath the device; however, this would not cause the positioning difficulty.The cause of positioning difficulty as reported is unknown; however, positioning can be influenced by the compatibility of the selected coil with the aneurysm¿s size and neck width.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.

• 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: 6650488
• MDR Text Key: 78097364
• Report Number: 2954740-2017-00173
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528007302
• UDI-Public: (01)00878528007302(17)201031(10)C39413
• 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: 05/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: CDF10051530
• Device Lot Number: C39413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1