MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 4MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035434080
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a aneurysmal coil embolization procedure was performed in internal carotid artery in a patient.During the procedure when the physician attempted to advance the subject coil through the microcatheter, the physician felt resistance and the subject coil detached prematurely in the proximal part of the microcatheter.The subject coil was replaced and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H3 summary attached - updated.H3 device evaluated by mfg ¿updated.H4 manufacturing date ¿ added.D4 expiration date - added.D10 product available to stryker ¿ updated.D10 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.Visual/microscopic inspection: the coil delivery wire was seen to be kinked.The main coil was seen to be still attached to the delivery wire but was seen to be extremely stretched/damaged.The coil suture was present and intact.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 'main coil prematurely detached/separated during use' was not confirmed during the analysis.The reported 'main coil damaged' was confirmed.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that no anomalies were noted to the device prior to use, the device was prepared as per the dfu (except continuous flush was not maintained for the duration of the procedure), the coil was not advanced or retracted with force, friction was noticed when pushing the coil in the microcatheter, the patient's anatomy was not tortuous, a microcatheter was used with the subject coil, and there were no allegations against the microcatheter used in the procedure.During analysis, the coil delivery wire was observed to be kinked.The main coil was still attached to the delivery wire, but was observed to be extremely stretched/damaged.The coil suture was present and intact.Since the coil was still attached to the delivery wire, not confirmed will be assigned to the as reported (ar) 'main coil prematurely detached/separated during use' as the issue included a returned product review (visual, physical, and/or performance testing) which showed no evidence of either the alleged issue(s) or any defect which could have contributed to the event.In the case of this complaint, it is possible that lack of continuous flush may have contributed to the coil damage as it could result in friction in the microcatheter during the procedure.Per the dfu, "in order to achieve optimal performance of the detachable coil system and to reduce the risk of thromboembolic complications, it is critical that a continuous infusion of appropriate flush solution be maintained between a) the femoral sheath and guiding catheter, b) the 2-tip microcatheter and guiding catheters, and c) the 2-tip microcatheter and stryker neurovascular guidewire and delivery wire.Continuous flush also reduces the potential for thrombus formation on, and crystallization of infuscate around, the detachment zone of the detachable coil." since the issue investigation confirmed that there was an act or omission of an act that resulted in a different medical product response than intended by the manufacturer and/or expected by the user, an assignable cause of use error will be assigned to the as analyzed (aa) 'main coil stretched' and the ar/aa 'main coil damaged'.An assignable cause of handling damage will be assigned to the aa 'coil delivery wire kinked/bent' since this issue is associated with 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.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that a aneurysmal coil embolization procedure was performed in internal carotid artery in a patient.During the procedure when the physician attempted to advance the subject coil through the microcatheter, the physician felt resistance and the subject coil detached prematurely in the proximal part of the microcatheter.The subject coil was replaced and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET HELICAL ULTRA 4MM 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: 13573323
• Report Number: 3008881809-2022-00075
• Device Sequence Number: 5644188
• Product Code: HCG
• UDI-Device Identifier: 04546540676115
• UDI-Public: 04546540676115
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 05/26/2022

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: 02/23/2023
• Device Model Number: M0035434080
• Device Catalogue Number: M0035434080
• Device Lot Number: 22161984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2020
• 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: CATALYST DISTAL ACCESS CATHETER 5 (STRYKER); EXCELSIOR SL-10 MICROCATHETER (STRYKER); NEURO MAX ACCESS SHEATH (PENUMBRA INC)
• Patient Age: 74 YR
• Patient Sex: Female