MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 8MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036128300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is not available to the manufacturer.
Event or Problem Description
It was reported that resistance was experienced while inserting the subject coil into the micro catheter, and when the subject coil was attempted to retract, the coil was stretched and was unable to retract, so the physician used a snare device to remove the subject coil.The product was exchanged and the procedure was completed successfully.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
D4 expiration date - added.H4 manufacturing date ¿ added.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not returned.Therefore, visual and functional analysis were not performed.The reported event is covered in the device directions 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.It is possible that the anatomical or procedural factors encountered during the procedure contributed to the reported events, but this cannot be conclusively determined.While there are a number of potential causes for the reported issues 'main coil difficulty inserting', 'coil difficulty to remove/withdraw from catheter', and 'main coil stretched', because review and analysis of available information failed to identify a definitive cause, a cause of 'undeterminable' was assigned.The reported issue 'patient medical or surgical intervention required' is a known and anticipated complication to these types of procedures and patient condition and are listed as such in the device direction for use.Therefore, a probable cause of 'anticipated procedural complication' was assigned to this event.
Event or Problem Description
It was reported that resistance was experienced while inserting the subject coil into the micro catheter, and when the subject coil was attempted to retract, the coil was stretched and was unable to retract, so the physician used a snare device to remove the subject coil.The product was exchanged and the procedure was completed successfully.There were no reported clinical consequences to the patient.

• Brand Name: TARGET XL 360 SOFT 8MM X 30CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9709203
• Report Number: 3008881809-2020-00042
• Device Sequence Number: 3474517
• Product Code: HCG
• UDI-Device Identifier: 07613327004649
• UDI-Public: 07613327004649
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/18/2022
• Device Model Number: M0036128300
• Device Catalogue Number: M0036128300
• Device Lot Number: 21447700
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR