MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 5MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036180520
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the coil embolization procedure performed for gastrointestinal bleeding treatment, a coil (subject device) was inserted inside the patient¿s anatomy in combination with a microcatheter.The subject coil prematurely detached without detachment attempt inside the microcatheter.The detached subject coil was removed from the patient's anatomy along with the microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date ¿ added.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual and functional inspection were not performed because product was not returned the reported event is covered in the device directions for use direction for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.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 and the device was not returned, an assignable cause of undeterminable will be assigned to main coil prematurely detached/separated during use.
Event or Problem Description
It was reported that during the coil embolization procedure performed for gastrointestinal bleeding treatment, a coil (subject device) was inserted inside the patient¿s anatomy in combination with a microcatheter.The subject coil prematurely detached without detachment attempt inside the microcatheter.The detached subject coil was removed from the patient's anatomy along with the microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET XXL 360 5MM X 20CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11995854
• Report Number: 3008881809-2021-00249
• Device Sequence Number: 3215628
• Product Code: HCG
• UDI-Device Identifier: 07613327466379
• UDI-Public: 07613327466379
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/21/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/03/2022
• Device Model Number: M0036180520
• Device Catalogue Number: M0036180520
• Device Lot Number: 21979519
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 09/21/2021
• 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: BREAKTHROUGH 0.021 MICROCAT (BOSTON SCIENTIFIC)