MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-14 STRAIGHT 300-35CM; WIRE, GUIDE, CATHETER

Catalog Number	M00313310
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during middle cerebral artery stenosis procedure, the physician used a balloon catheter to dilate.After placing the subject guidewire at the target lesion, the tip of the subject guidewire could not rotate during twisting.The physician felt that the subject guidewire might be fractured.However, a follow up response was received from the customer on (b)(6) 2023 confirming that the subject guidewire was stretched and not fractured.Later on (b)(6) 2023 the product investigation team shared a picture of the returned subject guidewire along with few follow up queries requesting for additional information.The picture shared confirmed that subject guidewire was broken.The investigation of the subject guidewire is anticipated but not yet begun.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
There are controls in the manufacturing process to ensure the product met specifications upon release.During visual/microscopic inspection: the guidewire was returned in three fragments.(264cm proximal fragment and 33.3cm and 5.5cm distal fragment).The guidewire was noted to be kinked at 41cm and 45cm from the proximal end.The distal fragment was inspected, and the nitinol tubing was broken/fractured with the core wire exposed and the platinum wire stretched.The core wire was intact.The proximal fragment was inspected, and the core wire was seen to be broken, after removing the dry blood, the core wire looks to be corroded.The core wire distal end was observed through the distal tip dome.Functional inspection was not applicable as the guidewire was broken/fractured.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 event 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 moderately tortuous.During analysis the guidewire was returned in two fragments (264cm, 33.3cm and 5.5cm).There was a second break along the core wire with some corrosion present.The guidewire was slightly kinked at 45cm.An assignable cause of procedural factors will be assigned to the as reported ¿guidewire torque problem¿, ¿guidewire distal tip stretched¿ and ¿guidewire distal tip broken/fractured during use¿ 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 as analyzed ¿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.An assignable cause of procedural factors will be assigned to the as analyzed ¿guidewire distal tip stretched¿, ¿guidewire distal tip broken/fractured during use¿ and ¿guidewire broken/fractured during use¿ 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.
Event or Problem Description
It was reported that during middle cerebral artery stenosis procedure, the physician used a balloon catheter to dilate.After placing the subject guidewire at the target lesion, the tip of the subject guidewire could not rotate during twisting.The physician felt that the subject guidewire might be fractured.However, a follow up response was received from the customer on (b)(6) 2023 confirming that the subject guidewire was stretched and not fractured.Later on 03-oct-2023 the product investigation team shared a picture of the returned subject guidewire along with few follow up queries requesting for additional information.The picture shared confirmed that subject guidewire was broken.The investigation of the subject guidewire is anticipated but not yet begun.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
It was reported that during middle cerebral artery stenosis procedure, the physician used a balloon catheter to dilate.After placing the subject guidewire at the target lesion, the tip of the subject guidewire could not rotate during twisting.The physician felt that the subject guidewire might be fractured.However, a follow up response was received from the customer on 01-oct-2023 confirming that the subject guidewire was stretched and not fractured.Later on 03-oct-2023 the product investigation team shared a picture of the returned subject guidewire along with few follow up queries requesting for additional information.The picture shared confirmed that subject guidewire was broken.The investigation of the subject guidewire is anticipated but not yet begun.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 from k032146 to k002907 in accordance with the global unique device identification database (gudid).

• Brand Name: SYNCHRO-14 STRAIGHT 300-35CM
• 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: 17901711
• Report Number: 3012931345-2023-00222
• Device Sequence Number: 7635755
• Product Code: DQX
• UDI-Device Identifier: 07613252186946
• UDI-Public: 07613252186946
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K002907
• 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): 08/15/2024

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: 02/07/2025
• Device Catalogue Number: M00313310
• Device Lot Number: 0000222883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 11/30/2023; 08/14/2024
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 12/21/2023; 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2023
• 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: BALLOON CATHETER (UNKNOWN).; EXCELSIOR XT-27 MICROCATHETER (STRYKER).
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Race: Asian