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

Catalog Number SSR10051020

Device Problem Knotted (1340)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2016

Event Type  malfunction  

Manufacturer Narrative

This is one of one initial mdr report being submitted for this complaint with associated mfr# 2954740-2016-00279.Additional procode: krd.(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.No conclusions are made at this time.

Event Description

As reported by a health care professional, during the procedure after 3 failed attempts to use the micrusphere xl 5mm x 10 cm coil (ssr10051020/c28152) in the patient they discovered that there was a knot on the coil.The procedure was completed with a same like product.There were no adverse events.It was initially reported that the complaint product is available for return.

Manufacturer Narrative

This is one of one final mdr report being submitted for this complaint with associated mfr# 2954740-2016-00279.The root cause of the knot on the coil cannot be determined.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.Therefore, no corrective actions will be taken at this time.

Manufacturer Narrative

This is follow-up mdr report being submitted for this complaint with associated mfr# 2954740-2016-00279.Complaint product returned for analysis.Limited information was received.The unidentified microcatheter and the rotating hemostatic valve (rhv) were not returned.Concerning cleanliness only, the microcoil system was returned in almost pristine condition.The system was either not used or was cleaned before being returned which may have produced further damage.It is also unknown if the device was improperly handled for returned packaging or was further manipulated and/or inspected post-procedurally.In addition, any trace or other evidence that may have been complaint related may have been altered or removed prior to being returned due to post-procedural handling, cleaning, and packaging.All location and measurement callouts are approximate and for reference only.As viewed through the returned packaging, unreported damage of the coil being severed, stretched, and separately wrapped in a cloth was found.The circumstances of how and when the unreported damage of the coil stretching and severing occurred cannot be determined.The proximal; section of the coil was still attached to the device positioning unit (dpu.) the proximal length of the coil was stretched.It was found that the fracture of the coil that caused it to severe was ductile in nature requiring external force.No material defects were found.It is confirmed that the coil was knotted and stretched proximally off the knotted section.No manufacturing defects were found.The complaint of the knot on the coil is confirmed.While the exact root cause of the coil knotting and its unreported damage of stretching and severing cannot be determined, the evidence as received highly suggests that the most likely contributing factor to the coil knotting and the unreported damage may have occurred during removal of the coil.There is insufficient inner diameter of the microcatheter or the introducer sheath for coil knotting to occur, therefore the evidence points toward the coil knotting between the rhv and the distal tip of the green introducer as this would have been impossible to occur inside the patient.When the knotting coil was retracted, it was anchored at the distal tip green introducer or in the rhv causing the stretching and eventual severing of the coil.Also, it has been noted that a quick retraction of the coil can produce similar results of stretching and severing by coming anchored on the distal tip of the green introducer.In addition, without the identification or the return of the unknown microcatheter and the rhv used in the procedure, it cannot be determined if these components contributed to the complaint event.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.The reported complaint of a knot on the complaint coil is confirmed.Although a definitive conclusion cannot be made, based on the analysis, it appears that procedural factors related to the removal of the coil possibly contributed to the event.Without return of concomitant products it cannot be determined if those components had any additional contributions to the complaint event.Additionally, review of this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, 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: 6121936
• MDR Text Key: 60856619
• Report Number: 2954740-2016-00279
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528009801
• UDI-Public: (01)00878528009801(17)190630(10)C28152
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K142429
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: SSR10051020
• Device Lot Number: C28152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1