MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSPHERE XL 18 SYSTEM PLATINUM MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	SSR18174020
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Procode: krd/hcg.Concomitant medical products: prowler select lpes microcatheter (606s155fx/17423598).(b)(6).Additional information will be submitted within 30 days of receipt.This is 1 of 2 mdrs being submitted for the event, with associated report numbers of 3008264254-2017-00118.
Event or Problem Description
As reported by a healthcare professional, during coil embolization of a cerebral aneurysm, the micrusphere xl coil (ssr18174020/ s11164) detached inside the prowler select lpes microcatheter (606s155fx/17423598) during initial use of the product, and both devices were removed from the patient without causing any damage or exposing the patient to risk.New devices of the same type were opened for continuity of the surgical procedure.The devices were discarded by the customer.
Additional Manufacturer Narrative
Additional information was received on 24 aug 2017: a continuous irrigation was maintained with saline solution under pressure in the microcatheter and in the guide catheter.There had been no attempt to detach the coil or withdraw the coil through the microcatheter prior to the detachment.The same detachment system worked properly after the event.There was resistance in the advancement of the microcoil inside the prowler at the same time as the inadvertent detachment of the device.All operating instructions were following while using the devices.There were no apparent defects in the microcatheter, and there was no problem with previous coils going through the microcatheter.The event did not cause any injury to the patient, but delayed the procedure 10 minutes to exchange the microcatheter.As reported by a healthcare professional, during coil embolization of a cerebral aneurysm, the micrusphere xl coil (ssr18174020/ s11164) detached inside the prowler select lpes microcatheter (606s155fx/17423598) during initial use of the product, and both devices were removed from the patient without causing any damage or exposing the patient to risk.A continuous irrigation was maintained with saline solution under pressure in the microcatheter and in the guide catheter.There had been no attempt to detach the coil or withdraw the coil through the microcatheter prior to the detachment.The same detachment system worked properly after the event.There was resistance in the advancement of the microcoil inside the prowler at the same time as the inadvertent detachment of the device.All operating instructions were following while using the devices.There were no apparent defects in the microcatheter, and there was no problem with previous coils going through the microcatheter.The event did not cause any injury to the patient, but delayed the procedure 10 minutes to exchange the microcatheter.New devices of the same type were opened for continuity of the surgical procedure.The devices were discarded by the customer.Product file (b)(4): the micrusphere xl 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.Product file (b)(4): during the review of the lot 17423598 it was noted that 2 units were rejected due to the defect of tight id.And they could be related to the reported complaint.However, the dhr review confirmed that the rejected units were properly segregated and discarded.No other issues were noted that were considered potentially related to the reported complaint.The restance between the micrusphere xl and the prowler select lpes and the coil detachment could not be confirmed without product return for analysis.The root cause of the events could not be determined; however, procedural/handling factors may have contributed to the events.The detachment may have been cause by the resistance.There is no current safety signal identified related to the reported events based on reviews of complaint histories for the devices.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.This is 1 of 2 mdrs being submitted for the event, with associated report numbers of 3008264254-2017-00118.

• Brand Name: MICRUSPHERE XL 18 SYSTEM PLATINUM MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6816342
• Report Number: 2954740-2017-00233
• Device Sequence Number: 163235
• Product Code: HCG
• UDI-Device Identifier: 00878528009849
• UDI-Public: (01)00878528009849(17)210731(10)S11164
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K073442
• 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): 08/01/2017

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: 07/31/2021
• Device Catalogue Number: SSR18174020
• Device Lot Number: S11164
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2017
• Supplement Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 08/24/2017
• Supplement Report FDA Received Date: 09/18/2017
• Patient Sequence Number: 1