MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 2MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036122060
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil (subject device) encountered resistance while was advancing the introducer sheath and it got stuck at the distal of the microcatheter, there was feeling that the coil (subject device) got kinked.Therefore, an attempt was made to retrieve the coil (subject device).However, it was prematurely detached inside of the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
The device is not available to the manufacturer.
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 (manufacturing execution system) system, there are controls in the manufacturing process to ensure the product met specifications upon release.During a visual inspection, the delivery wire was seen to be kinked, the coil was seen to be detached from the delivery wire, there was dried blood/procedural fluids seen on the delivery wire distal and detachment zone, and the coil was not returned for analysis.A functional test was not carried out as the coil was detached and not returned.The reported 'main coil prematurely detached/separated during use' was confirmed during analysis.The reported 'coil in catheter friction', 'coil introducer sheath friction' and 'main coil kinked/bent' could not be confirmed during analysis as the coil was not returned.The device failed to meet specification when received for complaint investigation based on the analyzed anomalies noted to the device.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 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 kinked.The coil was seen to be detached from the delivery wire.Therefore the reported code ¿main coil prematurely detached/separated during use¿ can be confirmed.The reported and analyzed 'main coil prematurely detached/separated 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.The analyzed 'coil delivery wire kinked bent' 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.An assignable cause of 'not confirmed' was assigned to the reported defect 'coil introducer sheath friction¿, ¿coil in catheter friction¿ and ¿main coil kinked/bent¿ 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.
Event or Problem Description
It was reported that the coil (subject device) encountered resistance while was advancing the introducer sheath and it got stuck at the distal of the microcatheter, there was feeling that the coil (subject device) got kinked.Therefore, an attempt was made to retrieve the coil (subject device).However, it was prematurely detached inside of the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET XL 360 SOFT 2MM X 6CM
• 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: 13375902
• Report Number: 3008881809-2022-00040
• Device Sequence Number: 20130081
• Product Code: HCG
• UDI-Device Identifier: 07613327128260
• UDI-Public: 07613327128260
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2022

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: 02/24/2024
• Device Model Number: M0036122060
• Device Catalogue Number: M0036122060
• Device Lot Number: 22747931
• 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: 01/25/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2021
• 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: TARGET XL 360 SOFT 4MM X 12CM (STRYKER)
• Patient Sex: Unknown