MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-10 STRAIGHT 200CM; WIRE, GUIDE, CATHETER

Catalog Number	M00316310
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during an intracranial arteriovenous malformations embolization case when the physician was manipulating the subject guidewire, the green polytetrafluoroethylene (ptfe) coating of the middle to the proximal peeled off and the operator felt bad manipulation of the subject guidewire.The subject guidewire was replaced, and the procedure was completed with no clinical consequences to the patient.
Additional Manufacturer Narrative
H3 other text : the device is not available for evaluation.
Event or Problem Description
It was reported during an intracranial arteriovenous malformations embolization case when the physician was manipulating the subject guidewire, the green polytetrafluoroethylene (ptfe) coating of the middle to the proximal peeled off and the operator felt bad manipulation of the subject guidewire.The subject guidewire was replaced, and the procedure was completed with no clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated (manufacturing execution system) mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the guidewire was noted to be kinked at 187cm from the proximal end of the guidewire.The guidewire polytetrafluoroethylene (ptfe) coating was seen to be peeling in numerous areas along the guidewire.The core wire distal end was observed through the distal tip dome.A functional inspection for the reported event ¿guidewire ptfe coating peeling¿ was not performed as the defect was confirmed during visual analysis.A functional inspection for the reported ¿guidewire torque problem¿ could not be replicated during device analysis; however, the analysis results are consistent with the reported event.The torque was not returned but the distal end of the guidewire was severely kinked.It is probable this caused torquing issues.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 complaint was confirmed based on analysis.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 there was no damage noted to the packaging prior to opening the packaging, there was no anomalies noted to the device during initial inspection and preparation, the device was prepared for use as per the directions for use, continuous flush was set up and maintained throughout the clinical procedure.The patient¿s anatomy was not tortuous.During analysis, the guidewire was seen to be severely kinked at the distal end.It is probable this was the cause of issue while torquing.The ptfe was peeling in numerous locations along the guidewire.An assignable cause of 'handling damage' will be assigned to the reported event of guidewire torque problem, as the defect appears to be associated with handling of the product or portion of the product during removal from the hoop and preparation.An assignable cause of procedural factors will be assigned to the reported and analyzed damage of the guidewire ptfe coating peeling as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.An assignable cause of 'handling damage' will be assigned to the analyzed damage of the guidewire kinked/bent, as the defect appears to be associated with handling of the product or portion of the product during removal from the hoop and preparation.
Additional Manufacturer Narrative
We have addressed the fda request, received via email on 14 june 2024: ¿upon review, we have determined that the device identification information about the suspect medical devices conflicts with the data submitted to the global unique device identification database (gudid)." "discrepancies were noted in the information included for some or all of the device identification fields of the electronic equivalent of the fda form 3500a compared to the information included for the corresponding fields in the gudid." "additionally, the ¿unique device identifier (udi) #¿ field on the fda form 3500a should contain the entire udi number including the di and pi fields, all numbers, letters, parentheses, and symbols.Please verify that you have included the entire udi in the ¿unique device identifier (udi) #¿ field on the 3500a." we have reviewed the device identifier (di) and confirm that it is accurate and in alignment with the hl7 specifications released in 2017.Additionally: the 510(k) number has been corrected from k032146 to k023700 in accordance with the global unique device identification database (gudid).
Event or Problem Description
It was reported during an intracranial arteriovenous malformations embolization case when the physician was manipulating the subject guidewire, the green polytetrafluoroethylene (ptfe) coating of the middle to the proximal peeled off and the operator felt bad manipulation of the subject guidewire.The subject guidewire was replaced, and the procedure was completed with no clinical consequences to the patient.

• Brand Name: SYNCHRO-10 STRAIGHT 200CM
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 18097633
• Report Number: 3012931345-2023-00240
• Device Sequence Number: 5429281
• Product Code: DQX
• UDI-Device Identifier: 07613252187158
• UDI-Public: 07613252187158
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K023700
• 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,Followup
• Report Date (Section B): 08/14/2024

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: 05/10/2024
• Device Catalogue Number: M00316310
• Device Lot Number: 0000132153
• 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: 10/20/2023
• Supplement Date Received by Manufacturer: 11/17/2023; 08/14/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 12/13/2023; 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2022
• 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: MICROCATHETER (MARATHON).
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Race: Asian