MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC MICRUSPHERE XL PLATINUM MICROCOIL; CNV DCS COILS

Catalog Number SSR10035720

Device Problems Difficult To Position (1467); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2015

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned for analysis therefore the root cause of the reported event cannot be determined.The sterile lot number was not provided for the device therefore the device history record review could not be conducted.Based on the information, the event could not be confirmed.The product was not returned for analysis and a device history record review cannot be completed because the lot for the product is unknown.Since the event could not be confirmed and there is no evidence of a manufacturing-related malfunction, no corrective actions will be taken at this time.This report is related to report # 2954740-2015-00197.

Event Description

The codman representative received a text message from a physician stating that he couldn't traverse the presidio (pc410041230/lot unknown) coil delivery system through the echelon 14 microcatheter (mc) and encountered a lot of friction during a right middle cerebral artery aneurysm embolization.Another coil a micrusphere (ssr10035720/lot unknown) had a tail protruding into the aneurysm neck with possible stretching after it was placed in and out of the aneurysm 5 times.An echelon 14 mc (details unknown) and synchro guidewire were used to access the aneurysm.The presidio was selected as the first coil but was not deployed as friction in the mc kept the doctor from advancing the entire coil into aneurysm.Next the echelon 14 mc was replaced with a new one (details unknown.) the micrusphere was then selected and after several deployments into the aneurysm the physician did not like the way the coil was laying at the neck, with a tail poking out.The physician says the coil may have stretched.The micrusphere was then removed and discarded.There was no friction felt when advancing the micrusphere.Finally, a target 360 ultrasoft 2x4 was deployed in the aneurysm and the procedure ended.The patient did not suffer any injury related to the issue.No additional information could be gathered.The devices were not saved and therefore cannot be returned for investigation.

• Brand Name: MICRUSPHERE XL PLATINUM MICROCOIL
• Type of Device: CNV DCS COILS
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: kimberly soter ; 821 fox lane; san jose, CA 95131 ; 5089777396
• MDR Report Key: 5005390
• MDR Text Key: 25490579
• Report Number: 2954740-2015-00198
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Report Date: 07/23/2015

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 Catalogue Number: SSR10035720
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1