MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 10MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036181040
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	12/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
The coil (subject device) experienced resistance in the catheter.When the physician pulled back the coil, the coil became stretched and had detached prematurely.Additionally, there may be thrombus in the microcatheter.There were no clinical consequences to the patient.
Event or Problem Description
The coil (subject device) experienced resistance in the catheter.When the physician pulled back the coil, the coil became stretched and had detached prematurely.Additionally, there may be thrombus in the microcatheter.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly, and performance specifications.Visual and microscopic examination of the returned device found that the returned microcatheter was kinked at the strain relief, the main coil was noted to be prematurely detached at the detachment zone, and there were no anomalies noted to the main.Functional testing was performed.The microcatheter was flushed without difficulty, there was no evidence of blood or thrombus within the microcatheter.A mandrel was able to be passed through the inner lumen of the microcatheter, friction was experienced at the distal kink.Based on the analysis, the reported event was confirmed.Information available indicated that the device was confirmed to be in good condition prior to use.Based on the investigation results and available information, it is possible that the microcatheter was damaged during the clinical procedure causing the difficulty advancing the coil through the microcatheter and the subsequent premature detachment of the coil within the microcatheter.An assignable cause of caused by other will be assigned to the as reported issue, coil in catheter friction and main coil prematurely detached/ separated inside patient.There was no evidence of thrombosis within the microcatheter during analysis, and there was no evidence of stretching to the main coil, therefore an assignable cause of not confirmed will be assigned to patient thrombosis (untreated vessel) and main coil stretched.

• Brand Name: TARGET XXL 360 10MM X 40CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8233906
• Report Number: 3008881809-2019-00015
• Device Sequence Number: 16420698
• Product Code: HCG
• UDI-Device Identifier: 07613327128406
• UDI-Public: 07613327128406
• Combination Product (Y/N): N
• PMA/510(K) Number: K161429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: M0036181040
• Device Lot Number: 19679421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Initial Date Received by Manufacturer: 12/27/2018
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICRO CATHETER ESTREAM 2.0 (TORAY MEDICAL); MICRO CATHETER ESTREAM 2.0 (TORAY MEDICAL)
• Outcome Attributed to Adverse Event: Other