MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036125150
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, during delivery the physician decided to re-sheath the subject coil, then redeliver the subject coil into the microcatheter.The subject coil got stuck in the distal third of the microcatheter and could not be retracted.The subject coil detached whilst in the microcatheter.No further information is available.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated.D9 product available to stryker- updated.D9 returned to manufacturer on- updated.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During the visual inspection, the device was returned without the introducer sheath and transport hoop.The coil delivery wire was seen to be kinked/bent in multiple areas.The main coil was seen to be kinked/bent.The delivery wire was seen to be broken/ fractured at the detachment zone.During the functional inspection, the main coil was returned inside the microcatheter which was analyzed, and the coil was removed.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.The reported complaint was confirmed based on device analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that after re-sheathing the coil it was re-delivered into the microcatheter and advanced through the microcatheter.The coil got stuck in the distal third of the microcatheter and detached inside the microcatheter.Based on the device analysis it was confirmed that the coil detached due to a physical break of the delivery wire (pi wire).The device was confirmed to be in good condition prior to use and there is no evidence that a use error contributed to the reported events.The patients anatomy was noted to be moderately tortuous.An assignable cause of procedural factors will be assigned to the reported events 'main coil prematurely detached/ separated during use', 'coil jammed' and 'coil in catheter friction' and to the as analyzed 'coil jammed', 'coil delivery wire broken/fractured during use' and 'main coil kinked/bent'.The issue appears to be associated with a product that meets stryker design and manufacture specifications and was used in accordance with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.An assignable cause of handling damage will be assigned to the analysed 'coil delivery wire kinked/bent' as the issue is due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.
Event or Problem Description
It was reported that during the procedure, during delivery the physician decided to re-sheath the subject coil, then redeliver the subject coil into the microcatheter.The subject coil got stuck in the distal third of the microcatheter and could not be retracted.The subject coil detached whilst in the microcatheter.No further information is available.

• Brand Name: TARGET XL 360 SOFT 5MM X 15CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 20758289
• Report Number: 3008881809-2024-00558
• Device Sequence Number: 8393226
• Product Code: HCG
• UDI-Device Identifier: 07613327128291
• UDI-Public: (01)07613327128291(17)270423(10)24910890
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123377
• 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): 12/26/2024

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 Catalogue Number: M0036125150
• Device Lot Number: 24910890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SL-10 MICROCATHETER (STRYKER).
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Race: White