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

Catalog Number SSR10072020

Device Problems Difficult To Position (1467); Physical Resistance (2578); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2017

Event Type  malfunction  

Manufacturer Narrative

Product code: krd/hcg.It is anticipated that the device will be returned for analysis; however, the device has not yet been returned.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a healthcare professional, during coil embolization of an anterior communicating artery aneurysm, the microsphere xl (ssr10072020/ s10848) kicked back the echelon 10 catheter (inner diameter 0.017) and protruded into the parent vessel during deployment of the last loop, and when attempting to re-deploy the coil, it could not enter the microcatheter hub due to stiff resistance.There had not been resistance when the coil was initially implanted and withdrawn from the microcatheter.The physician removed the coil and deployed a competitor coil to complete the procedure using the same microcatheter.A continuous flush had been maintained through the microcatheter.There was no patient injury or procedure delay.

Manufacturer Narrative

The device was returned for analysis; however, the analysis has not yet been completed.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Conclusion: as reported by a healthcare professional, during coil embolization of an anterior communicating artery aneurysm, the micrusphere xl (ssr10072020/ s10848) kicked back the echelon 10 catheter (inner diameter 0.017) and protruded into the parent vessel during deployment of the last loop, and when attempting to re-deploy the coil, it could not enter the microcatheter hub due to stiff resistance.There had not been resistance when the coil was initially implanted and withdrawn from the microcatheter.The physician removed the coil and deployed a competitor coil to complete the procedure using the same microcatheter.A continuous flush had been maintained through the microcatheter.There was no patient injury or procedure delay.The device was returned tightly coiled; it was sheathed.There was a very slight kink in the core wire approximately 104 cm from the proximal end.The ball tip was intact and located at the proximal end of the green introducer.The skive of the translucent introducer sheath was open over the embolic coil; there is blood in the introducer and on the embolic coil.There were no kinks or stretched sections of the embolic coil.The articulating joint was enclosed in the translucent introducer sheath and could not be visualized.The v-notch was intact.Advancement was attempted.The embolic coil could not be advanced into the green introducer.Review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.Protrusion of the coil into the parent vessel is a known potential event associated with coil implantation procedures.The complaint that the embolic coil was impeded was confirmed.When advancement was attempted through the introducer, the embolic coil could not be moved.The evidence of the blood in the translucent introducer sheath indicates that insufficient flush may have been maintained during the procedure.The instructions for use (ifu) states that a continuous infusion of appropriate flush must be maintained for optimal performance, and cautions to verify that the flush is properly pressurized if there is friction during advancement or retraction.There is no current safety signal identified related to the reported events based on reviews of complaint histories 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 XL PLATINUM MICROCOIL
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• Manufacturer Contact: karen anigbo ; 821 fox lane; san jose, CA 95131 ; 5088288374
• MDR Report Key: 6794212
• MDR Text Key: 82784772
• Report Number: 2954740-2017-00228
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528009924
• UDI-Public: (01)00878528009924(17)210531(10)S10848
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K032872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: SSR10072020
• Device Lot Number: S10848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2017
• Initial Date FDA Received: 08/15/2017
• Supplement Dates Manufacturer Received: 09/14/2017; 10/09/2017
• Supplement Dates FDA Received: 10/09/2017; 10/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1