MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3.5MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035423580
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device remains implanted.
Event or Problem Description
It was reported that during the procedure, resistance was encountered when advancing the subject coil and the coil was prematurely detached and was left inside the patient.The procedure was delayed by 20 minute and the result was compromised.Clinical consequences were reported to the patient due to this event.No additional information was provided.
Additional Manufacturer Narrative
The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, visual, dimensional and functional testing could not be performed.In case of this complaint, no additional information was provided from the customer, but as reported the coil was stuck inside the catheter and was broken.It could be due to some procedural factors encountered during use; however, this cannot be confirmed.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned to the as reported issues main coil prematurely detached/separated inside patient, un-retrieved device fragments and patient complications.
Event or Problem Description
It was reported that during the procedure, resistance was encountered when advancing the subject coil and the coil was prematurely detached and was left inside the patient.The procedure was delayed by 20 minute and the result was compromised.Clinical consequent's were reported to the patient due to this event.No additional information was provided.

• Brand Name: TARGET 360 ULTRA 3.5MM X 8CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8670546
• Report Number: 3008881809-2019-00157
• Device Sequence Number: 10823787
• Product Code: HCG
• UDI-Device Identifier: 04546540714756
• UDI-Public: 04546540714756
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2019

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: 10/22/2021
• Device Catalogue Number: M0035423580
• Device Lot Number: 20954710
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 06/05/2019
• Supplement Report FDA Received Date: 07/17/2019
• 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: MICROCATHETER (UNKNOWN MANUFACTURER); MICROCATHETER (UNKNOWN MANUFACTURER)
• Patient Age: 35 YR