MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPAQ CERE 1.5MMX6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	CDF100156-30
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This initial mdr will be the only report submitted for mfr report #3008114965-2017-00509.Patient information has been requested but not reported at this time.Udi: lot number unknown; (b)(4).Lot number unknown, therefore manufacture and expiration dates are unknown.(b)(6).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 or Problem Description
It was reported by a healthcare professional that a deltapaq coil ((b)(4)/unknown lot) was used during a procedure and the coil could not be detached.This was the third coil used during the procedure.The coil was withdrawn and another coil was used to complete the procedure.There was no report of patient injury.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 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 or design issue, no corrective actions will be taken at this time.
Additional Manufacturer Narrative
Product complaint # (b)(4).This follow-up mdr will be the only report submitted for mfr report #3008114965-2017-00509.Additional information received on march 01, 2018: the lot number of the deltapaq is unknown.There was no damage noted to the device prior to use.The microcatheter information is unknown.There were no kinks or bends noted to the microcatheter that may have contributed to the reported event.There was no resistance encountered between the microcatheter and the deltapaq and the coil was not stretched when it was removed.The coil was still attached to the delivery system when it was removed from the patient.Only the deltapaq was removed from the patient as a result of this event.An enpower control cable and dcb were used, catalog and lot information is unknown.A pre-deployment check was performed and a low battery light was not seen during the case.The green system ready light illuminated.All connections appeared to fit properly without application of excessive force.The same connecting cable and dcb were used successfully both with subsequent coils and coils used prior to the reported event.The intended procedure was the embolization of an intracranial aneurysm.Patient information is not available.

• Brand Name: DELTAPAQ CERE 1.5MMX6CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 7131492
• Report Number: 3008114965-2017-00509
• Device Sequence Number: 1824513
• Product Code: HCG
• UDI-Device Identifier: 00878528007043
• UDI-Public: (01)00878528007043
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K080437
• 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): 11/21/2017

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 Model Number: CDF100156-30
• Device Catalogue Number: CDF10015630
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/21/2017
• Supplement Date Received by Manufacturer: 11/21/2017; 04/09/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 03/23/2018; 05/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1