MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 1.5MM X 3.0CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5411530
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during the anterior communicating artery aneurysm procedure, physician attempted to detach the subject coil however, power supply signaled that the subject coil did not detach.Physician checked under fluoroscopy and confirmed that the subject coil had not detached.However, the subject coil detached prematurely within the patient anatomy later while adjusting the microcatheter.The physician removed the subject coil using a stent retriever.There was surgical delay of 30 minutes noted.No further information is available.
Event or Problem Description
It was reported that during the anterior communicating artery aneurysm procedure, physician attempted to detach the subject coil however, power supply signaled that the subject coil did not detach.Physician checked under fluoroscopy and confirmed that the subject coil had not detached.However, the subject coil detached prematurely within the patient anatomy later while adjusting the microcatheter.The physician removed the subject coil using a stent retriever.There was surgical delay of 30 minutes noted.No further information is available.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes), there are controls in the manufacturing process to ensure the product met specifications upon release.During visual/microscopic inspection, the main coil was seen to be stretched.The main coil was seen to be kinked/bent.The main coil was seen to be electronically detached.Functional inspection was 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 confirmed during the analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.During analysis, the main coil was seen to be detached, stretched and kinked.This may have occurred due to manipulation or procedural factors as the physician pulled the coil back to see it had not detached.However, during a moment later when adjusting the microcatheter the coil detached.An assignable cause of ¿procedural factors¿ will be assigned to the as reported and as analyzed ¿main coil prematurely detached/separated during use¿ and as analyzed ¿main coil kinked/bent¿ and ¿main coil stretched¿ as these defects 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 TETRA 1.5MM X 3.0CM
• 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: 18847959
• Report Number: 3008881809-2024-00091
• Device Sequence Number: 18101029
• Product Code: HCG
• UDI-Device Identifier: 07613327580105
• UDI-Public: 07613327580105
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K222533
• 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): 05/15/2024

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: 09/16/2026
• Device Catalogue Number: TG5411530
• Device Lot Number: 24539841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2023
• 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: DAC 044 CATHETER (STRYKER); EMBROTRAP STENT RETRIEVER (UNKNOWN); EXCELSIOR SL-10 MICROCATHETER (STRYKER); HYPERFORM BALLOON (MEDTRONIC); INZONE DETACHMENT SYSTEM (STRYKER); NEURON MAX LONG SHEATH (PENUMBRA); SYNCHRO SELECT STANDARD GUIDEWIRE (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown