MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSPHERE XL 6MMX20CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	SSR100620-20
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This initial mdr will be the only report submitted for mfr report #3008114965-2018-00502.(b)(6).(b)(4).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 xl coil (b)(4) was used during a coil embolization procedure and the coil could not be detached.After positioning the coil in the aneurysm, several attempts were made to release the coil, but were unsuccessful.The cables were exchanged three times, however, the issue was not resolved.Therefore, the physician decided to remove the coil and replace it with another.
Additional Manufacturer Narrative
(b)(4).This final mdr will be the only report submitted for mfr report #3008114965-2018-00502.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.

• Brand Name: MICRUSPHERE XL 6MMX20CM
• 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: 7169187
• Report Number: 3008114965-2018-00502
• Device Sequence Number: 1823632
• Product Code: KRD
• UDI-Device Identifier: 00878528009955
• UDI-Public: (01)00878528009955(17)210331(10)S10248
• 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
• Report Date (Section B): 12/06/2017

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 Model Number: SSR100620-20
• Device Catalogue Number: SSR10062020
• Device Lot Number: S10248
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR