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

Catalog Number SSR10062020

Device Problems Kinked (1339); Premature Activation (1484); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Mfg name - codman & shurtleff, inc.Dba depuy synthes products, inc.No additional information could be provided.The customer did not know the initial complaint.No customer, procedure or complaint information, including date of event was known by the customer.Conclusion: the device was returned with its inner pouch.Labeling on the inner pouch matches the product documented in complaint (b)(4).The embolic coil is fully unsheathed, stretched, and tangled around the device positioning unit (dpu).The coil is detached from the dpu.The resheathing tool has been advanced all the way to the green introducer.The embolic coil was gently untangled from the dpu.There are kinks in the dpu core wire approximately 36 cm, 37 cm, 38 cm, 53 cm, 66 cm, 72 cm, 74 cm, 89 cm, 101 cm, 109 cm and 111 cm from the proximal end.The ball tip is intact.The primary wind is helical in shape.The embolic coil is kinked and stretched.The proximal loop and soldered ring are destroyed.The detachment fiber is missing from the distal end of the dpu.The resistance heating (rh) coil has not received heat and melted.The v-notch of the resheathing tool is undamaged.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The complaint that the device is damaged was confirmed.The embolic coil is kinked, stretched, and mechanically detached from the dpu, and the dpu core wire is severely kinked.These all indicate that the device was subject to application of excessive force, and it is not possible to determine if the damages occurred during a procedure or during post-procedure handling.The cause or reason for the excessive force cannot be determined from the returned device, and there is no event information provided by the customer.However, the ifu consistently instructs the user to use care and manipulate the device gently.In addition to the excessive force, the resheathing tool has been advanced all the way to the green introducer.The ifu instructs the user to leave approximately 1 inch of translucent introducer sheath visible between the resheathing tool and the introducer when placing the microcoil.Advancing the resheathing tool further can cause the translucent introducer sheath to tear beyond its existing skive, and could potentially prevent the sheath from re-forming if the device should need to be resheathed.There is no current safety signal identified related to the reported events based on review of complaint history for the device.Since there was no evidence to suggest the events were related to a manufacturing issue, no corrective actions will be taken at this time.This is an initial/final mdr report.

Event Description

At a healthcare facility, a used micrusphere xl coil (ssr10062020/ c31091) was found on the shelf and had been sitting there for up to a year; however, the facility did not know what the actual complaint had been.During product analysis, it was found that the coil was stretched, detached and kinked.The sales representative informed the customer about the importance of reporting any complaints as soon as possible to johnson and johnson.No additional information could be provided.

• Brand Name: MICRUSPHERE XL PLATINUM MICROCOIL
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle jura ; SZ
• Manufacturer Contact: joaquin kurz ; 47709 freemont blvd; freemont, CA 94538 ; 9497899383
• MDR Report Key: 7094924
• MDR Text Key: 95066650
• Report Number: 3013875781-2017-00041
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528009955
• UDI-Public: (01)00878528009955(17)191231(10)C31091
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K032872
• 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
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: SSR10062020
• Device Lot Number: C31091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1