MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-10 STRAIGHT 300CM; WIRE, GUIDE, CATHETER

Model Number	M00316330
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure for mca stenosis case, a guidewire was used to bring balloon catheter to target lesion.Physician then withdrew the initial guidewire and placed subject guidewire to continue procedure.When the subject guidewire was delivered along with the balloon catheter, physician found that the tip of the guidewire could not be seen under dsa and believed to have been delivered into vessel for about 1m.In order to avoid any risk, the physician replaced subject guidewire another of the same catalog to continue the procedure.The procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
The device was returned and the lot number was not confirmed as the packaging was not returned with the device.During visual inspection guidewire tip was shaped, and was kinked/bent 10.7cm from the distal end.The radiopaque platinum wire was visible through the dome at the distal tip.The device was placed under an x-ray machine and images were taken, the entire radiopaque distal platinum section from the distal bond to the distal tip was visible under fluoroscopy.The guidewire distal section and hydrophilic coating was examined along its length with wet fingers.The coating was present on the guidewire.The ptfe coating was examined under magnification and no anomaly was noted.No functional inspection was performed.Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.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 event was not confirmed based on analysis of the returned device.Additional information provided by the customer indicated that there was no damage noted to the packaging prior to opening the packaging, the device was confirmed to be in good condition during preparation/prior to use on the patient, the device was prepared for use as per the directions for use, continuous flush was set up and maintained throughout the clinical procedure and the patient¿s anatomy was not tortuous.The physician did not look at the guidewire after removal from patient anatomy and there was no intervention to remove the tip as the guidewire tip did not break and there was no tip fragment left within the patient¿s anatomy.The gateway was at mca and the synchro was pushed into the gateway about 1 meter, because the distal end of the synchro couldn't be seen so it wasn¿t known where the issue occurred and the physician had no idea what was the reason for the issue.The device was returned and a kink was present 10.7cm from the distal end.The guidewire radiopaque platinum wire was visible through the dome at the distal tip and the entire radiopaque distal platinum section from the distal bond to the distal tip was visible under fluoroscopy.Therefore, the as reported ¿nv ¿ ro marker(s) detached/separated/not visible under fluoroscopy¿ will be assigned ¿not confirmed¿.The as analysed ¿nv - guidewire distal end 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.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that during the procedure for mca stenosis case, a guidewire was used to bring balloon catheter to target lesion.Physician then withdrew the initial guidewire and placed subject guidewire to continue procedure.When the subject guidewire was delivered along with the balloon catheter, physician found that the tip of the guidewire could not be seen under dsa and believed to have been delivered into vessel for about 1m.In order to avoid any risk, the physician replaced subject guidewire another of the same catalog to continue the procedure.The procedure was completed successfully with no clinical consequences to the patient.

• Brand Name: SYNCHRO-10 STRAIGHT 300CM
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 11269969
• Report Number: 3012931345-2021-00027
• Device Sequence Number: 14100834
• Product Code: DQX
• UDI-Device Identifier: 07613252187165
• UDI-Public: 07613252187165
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K032146
• 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): 04/29/2021

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: 02/27/2021
• Device Model Number: M00316330
• Device Catalogue Number: M00316330
• Device Lot Number: 0000023254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GATEWAY BALLOON CATHETER (STRYKER); SYNCHRO GUIDEWIRE 200CM (STRYKER)
• Patient Age: 55 YR
• Patient Weight: 70