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

Model Number	M0035478300
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during posterior communicating artery (pcoma) aneurysm procedure, the physician placed a guide catheter, guidewire and microcatheter to build access to the aneurysm and deployed a stent.Then prepared to frame the subject coil to the treatment site.Physician felt friction while advancing the subject coil in the distal of the microcatheter and the subject coil was deployed prematurely inside the microcatheter.A snare device was used to retrieve the subject coil.The physician replaced it with a same new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the coil delivery wire was seen to be kinked.The main coil was seen to be still attached to the delivery wire and was intact.The proximal contact was seen to be broken/fractured.During function inspection, there was no introducer sheath returned so a demo sheath was used to try and complete the functional test for the reported coil in catheter friction but due to the damage on the proximal contact the delivery wire was unable to be reloaded into the demo sheath.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.Additional information provided by the customer indicated that the device was confirmed to be in good condition prior to use, the device was prepared as per the dfu, continuous flush was maintained throughout the clinical procedure, and resistance was noted while advancing the coil in the microcatheter.The main coil was found to be attached when returned for analysis therefore the as reported was not confirmed.However, a snare device was used to remove the fragment from patient's anatomy; therefore, this event does meet the criteria of a reportable event.The as reported 'main coil prematurely detached/separated during use' cannot be confirmed as the main coil was returned attached.The as reported 'main coil prematurely detached/separated during use' will be assigned not confirmed.The as reported 'coil in catheter friction' as well as the as analyzed 'coil delivery wire kinked bent' and 'coil proximal contact broken/fractured' will be assigned handling damage 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.There may have been friction felt when the kinked delivery wire was advancing through the microcatheter.Although the as analyzed codes are non-reportable, there was a medical intervention to retrieve the coil segment.Therefore, this event still meets the criteria of a reportable event.
Event or Problem Description
It was reported that during posterior communicating artery (pcoma) aneurysm procedure, the physician placed a guide catheter, guidewire and microcatheter to build access to the aneurysm and deployed a stent.Then prepared to frame the subject coil to the treatment site.Physician felt friction while advancing the subject coil in the distal of the microcatheter and the subject coil was deployed prematurely inside the microcatheter.A snare device was used to retrieve the subject coil.The physician replaced it with a same new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET 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 ; 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: 12742494
• Report Number: 3008881809-2021-00466
• Device Sequence Number: 4530202
• Product Code: HCG
• UDI-Device Identifier: 04546540676603
• UDI-Public: 04546540676603
• 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): 02/25/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/06/2023
• Device Model Number: M0035478300
• Device Catalogue Number: M0035478300
• Device Lot Number: 22429102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/10/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2020
• 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: 6F ENVOY GUIDE CATHETER (CODMAN); EN-10 MICROCATHETER (MEDTRONIC); EXCELSIOR XT-17 MICROCATHETER (STRYKER); NEUROFORM ATLAS STENT (STRYKER); SOLITAIRE STENT (MEDTRONICS); SYNCHRO GUIDEWIRE (STRYKER); 6F ENVOY GUIDE CATHETER (CODMAN); EN-10 MICROCATHETER (MEDTRONIC); EXCELSIOR XT-17 MICROCATHETER (STRYKER); NEUROFORM ATLAS STENT (STRYKER); SOLITAIRE STENT (MEDTRONICS); SYNCHRO GUIDEWIRE (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian