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	07/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 149.8cm from the proximal end of the guidewire.The guidewire polytetrafluoroethylene (ptfe) coating was seen to be peeling in 3 locations along the guidewire at 10.4cm, 14cm and 26cm from the proximal end.The core wire was observed through the distal tip dome.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 complaint was confirmed based on analysis of the returned device.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.It was reported by the physician that it is out of the box failure.The reported defect "guidewire kinked/bent" was confirmed during analysis and will be assigned a probable cause of handling damage.The analyzed defect ¿guidewire ptfe coating peeling¿ will be assigned a probable cause of handling damage.There was evidence of scraping and peeling of the ptfe guidewire coating in 3 locations along the guidewire from the proximal end.The peeling/scraping most likely occurred while removing the device from the hoop.Because this complaint appears to be associated with handling of the product or portion of the product upon removal of the product from the packaging, a probable cause of handling damage was assigned.
Event or Problem Description
The subject guidewire was returned for analysis and it was discovered that the subject guidewire ptfe (polytetrafluoroethylene) coating was noted to be peeling.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
The subject guidewire was returned for analysis and it was discovered that the subject guidewire ptfe (polytetrafluoroethylene) coating was noted to be peeling.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
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).

• 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: 17913955
• Report Number: 3012931345-2023-00225
• Device Sequence Number: 7525826
• 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
• Report Date (Section B): 08/15/2024

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
• Date Returned to Manufacturer: 08/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 08/15/2024
• 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
• Patient Sex: Unknown
• Patient Race: Asian