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

Catalog Number	DFS10102520
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is initial/final mdr report being submitted with associated mfr# 2954740-2017-00072; 2954740-2017-00073; 2954740-2017-00074; 2954740-2017-00075; 2954740-2017-00076 and 2954740-2017-00077.Additional procode: krd.(b)(4).The deltapaq will not be returned, therefore the root cause of the advancement difficulty and the coil stretching cannot be determined.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.Therefore, no corrective actions will be taken at this time.
Event or Problem Description
As reported by a health care professional, during an aneurysm coiling procedure the physician was unable to six pass coils through an unknown microcatheter.Upon trying again all the coils kinked.There were no damages noted on the complaint coils prior to use; however, it was reported that the coils were stretched when they were removed and they were removed along with the microcatheter.It is unknown if the catheter was removed for all the six coil and the target site for the coiling is unknown.The catheter used with the coils was reported to be kinked.No products were used with the concomitant devices prior to the encountered resistance.The procedure was completed using same like products.The healthcare professional also reported that a neuroscout guide wire did not pass through an unknown prowler catheter.There were no adverse events and the procedure was not prolonged due to the reported event.The complaint products are not available for return.
Additional Manufacturer Narrative
(b)(6).
Additional Manufacturer Narrative
(b)(6).

• Brand Name: DELTAPAQ - PLATINUM MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6497144
• Report Number: 2954740-2017-00077
• Device Sequence Number: 628416
• Product Code: HCG
• UDI-Device Identifier: 00878528007999
• UDI-Public: (01)00878528007999(17)210331(10)S00019
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K142429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: DFS10102520
• Device Lot Number: S00019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/03/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/17/2017
• Supplement Report FDA Received Date: 06/21/2017; 06/22/2017
• Patient Sequence Number: 1