MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035423080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not yet received for evaluation.
Event or Problem Description
It was reported that during the aneurysm procedure used a guide catheter and guidewire to bring the microcatheter to the target site.Physician deployed the stent in the target site and started filling the coils in the aneurysm when delivering the subject coil to the treatment site, the proximal section of the delivery wire was fractured.The device was replaced and the procedure was completed successfully with no clinical consequences to the patient.
Event or Problem Description
It was reported that during the aneurysm procedure used a guide catheter and guidewire to bring the microcatheter to the target site.Physician deployed the stent in the target site and started filling the coils in the aneurysm when delivering the subject coil to the treatment site, the proximal section of the delivery wire was fractured.The device was replaced and the procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
H4: manufacturing date ¿ added.H3: device evaluated by mfg ¿updated.H3: summary attached - updated.D4: expiration date - added.D9: product available to stryker ¿ updated.D9: returned to manufacturer on ¿updated.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned and the lot number was confirmed with the packaging returned with the device.During visual inspection, the delivery wire was seen to be broken just before the proximal contact junction.The main coil and introducer sheath were both intact.Functional testing was 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.The reported event was confirmed during the analysis.The device failed to meet specification when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient, the device was prepared as per the dfu.Also, additional information indicated that continuous flush was set up and maintained throughout the clinical procedure.During the analysis, the delivery wire was seen to be broken just before the proximal contact junction.Therefore the as reported and analyzed event of the coil delivery wire broken/fractured during use will be assigned procedural factors as 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.

• Brand Name: TARGET 360 ULTRA 3MM X 8CM
• 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: 13759058
• Report Number: 3008881809-2022-00117
• Device Sequence Number: 5936533
• Product Code: HCG
• UDI-Device Identifier: 04546540675897
• UDI-Public: 04546540675897
• 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): 05/25/2022

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: 05/31/2024
• Device Model Number: M0035423080
• Device Catalogue Number: M0035423080
• Device Lot Number: 22950061
• 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: 02/15/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2021
• 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: ENVOY GUIDE CATHETER (CODMAN).; EXCELSIOR SL-10 MICROCATHETER (STRYKER).; NEUROFORM ATLAS STENT (STRYKER).; SYNCHRO GUIDEWIRE (STRYKER).
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 62 KG
• Patient Race: Asian