MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 STANDARD 12MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035461230
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2022
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 left pcoma aneurysm case, the physician prepared a microcatheter to frame the subject coil.While inserting the subject coil into the aneurysm, it got stretched.On withdrawal, the subject coil was found fractured.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
D4 expiration date - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.H3 summary attached - updated.H3 device evaluated by mfg ¿updated.H4 manufacturing date- added.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection: the main coil was noted to be kinked/bend and stretched.The coil delivery wire was noted to be kinked/bent.The main coil was noted to be detached/separated.The main coil was noted to be broken/fractured.The coil introducer sheath was not returned.Functional inspection: not required.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 event was confirmed.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The product was returned.The information provided states that the coil was stretched during its insertion into an aneurysm, and when the operator extracted it, he discovered that it was fractured.The returned device was analyzed and the results are consistent with the reported event.The main coil was discovered to be kinked/bend, stretched, fractured and detached.The coil delivery wire was kinked.This complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.Therefore, an assignable cause of procedural factors will be assigned to as reported/as analyzed ¿main coil broken/fractured during use¿ and ¿main coil stretched¿ and to the as analyzed ¿main coil kinked/bent¿, coil delivery wire kinked/bent and ¿main coil prematurely detached/separated during use.
Event or Problem Description
It was reported that during left pcoma aneurysm case, physician prepared a microcatheter to frame the subject coil.While inserting the subject coil into the aneurysm, it got stretched.On withdrawal, the subject coil was found fractured.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET 360 STANDARD 12MM X 30CM
• 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: 16094108
• Report Number: 3008881809-2023-00003
• Device Sequence Number: 6529284
• Product Code: HCG
• UDI-Device Identifier: 07613252192503
• UDI-Public: 07613252192503
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/13/2023

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: 07/12/2023
• Device Model Number: M0035461230
• Device Catalogue Number: M0035461230
• Device Lot Number: 22333061
• 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: 12/12/2022
• Supplement Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2021
• 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: 6F LONG SHEATH (EVEOY DA); EXCELSIOR SL-10 MICROCATHETER (STRYKER); EXCELSIOR XT-27 MICROCATHETER (STRYKER); NEUROFORM EZ STENT (STRYKER); SYNCHRO GUIDEWIRE (STRYKER); TARGET COILS (STRYKER); UNKNOWN LONG SHEATH
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Race: Asian