MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSPHERE 10 - PLATINUM MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	SPH10060020
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This initial mdr is the only report being submitted for mfr report #3013875781-2017-00004.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 micrusphere coil (sph10060020/c22165) stretched during a procedure.Another one was used to complete the procedure.There was no report of patient injury.
Additional Manufacturer Narrative
This final mdr will be the only report submitted.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.
Additional Manufacturer Narrative
This follow-up mdr is the only report being submitted for mfr report #3013875781-2017-00004.The initial reporter listed on the initial mdr was incorrectly reported.The initial report information was requested, however it is unknown and unavailable.
Additional Manufacturer Narrative
This follow-up mdr will be the only report submitted for mfr report #3013875781-2017-00004.This mdr is being submitted to report the additional information received on january 03, 2018: the intended procedure was coil embolization of an intracranial aneurysm.There was no damage noted to the coil prior to the procedure and no kinks or bends were noted to the microcatheter that may have contributed to the reported event.An adequate continuous flush was maintained through the microcatheter at all times.No resistance was experienced during advancement of the coil through the microcatheter.The event occurred during advancement into the aneurysm.Coil entanglement with previously placed coils did not contribute to the event.The entire coil was withdrawn and removed from the patient.The patient has reportedly recovered post procedure.There was no procedural delay as a result of this event.

• Brand Name: MICRUSPHERE 10 - PLATINUM MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle jura ; SZ
• MDR Report Key: 6954281
• Report Number: 3013875781-2017-00004
• Device Sequence Number: 16421791
• Product Code: KRD
• UDI-Device Identifier: 00878528003564
• UDI-Public: (01)00878528003564(17)181031(10)C22165
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: SPH10060020
• Device Lot Number: C22165
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/20/2017
• Supplement Date Received by Manufacturer: 12/07/2017; 01/03/2018; 01/09/2018
• Initial Report FDA Received Date: 10/17/2017
• Supplement Report FDA Received Date: 01/02/2018; 01/07/2018; 01/12/2018
• Patient Sequence Number: 1