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

Catalog Number	SPH10035020
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mfg name - codman & shurtleff, inc.Dba depuy synthes products, inc.Three attempts to obtain additional information and product return were unsuccessful.It was reported that the device would be returned for analysis; however, it has not yet been returned additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, during the procedure, the micrusphere coil (sph10035020/p10043) stretched.Used another one to complete the procedure.There was no report on the patient injury.
Additional Manufacturer Narrative
It was reported that the device would be returned for analysis; however, the device was not returned and no additional information was provided.If product or additional information becomes available at a later date, a supplemental mdr will be submitted.Conclusion: as reported by a healthcare professional, during the procedure, the micrusphere coil (sph10035020/p10043) stretched.Used another one to complete the procedure.There was no report on the patient injury.It was reported that the device would be returned for analysis; however, after multiple requests, the device was not returned and no additional information provided.The msphere 10 plat product was not returned for investigation.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The coil stretch could not be confirmed without product return for analysis.The root cause of the event could not be determined.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: 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: 6947136
• Report Number: 1226348-2017-00172
• Device Sequence Number: 11064844
• Product Code: HCG
• UDI-Device Identifier: 00878528003533
• UDI-Public: (01)00878528003533(17)200430(10)P10043
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K002056
• 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
• 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: 04/30/2020
• Device Catalogue Number: SPH10035020
• Device Lot Number: P10043
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/20/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 10/13/2017
• Supplement Report FDA Received Date: 11/30/2017
• Patient Sequence Number: 1