MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-14 STRAIGHT 200-35CM; WIRE, GUIDE, CATHETER

Catalog Number M00313010

Device Problem Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2023

Event Type  malfunction  

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.The device was returned and the lot number was confirmed with the packaging returned with the device.During visual inspection the guidewire distal end appeared to have been over-shaped similar to an ¿m¿ shape where the bends were noted 0.7cm and 1.2cm from the distal end.The guidewire was noted to have intermittent ptfe peeling from the proximal end to 30.2cm from the proximal end.The core wire distal end was observed through the distal tip dome.The guidewire was soaked in water.After soaking the guidewire, it was inspected wet.The hydrophilic coating was intact.The guidewire distal tip revealed slight swelling/bulge on its distal tip and traces of procedural fluid was evident.When dry after approximately 30 seconds, the distal tip showed no anomaly and the swelling/bulge had disappeared.The torque device was not returned.During the functional inspection difficulty was experienced inserting the guidewire through the flushed demonstration microcatheter hub due to the over-shaped distal end.Friction/resistance was experienced as the guidewire was advanced through the microcatheter but it exited the distal end.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 indicates 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, the dispenser hoop flushed before removing the guidewire, there was no resistance encountered removing the guidewire from the dispenser hoop, continuous flush was set up and maintained throughout the clinical procedure, there was no friction/resistance encountered during the procedure and there were no coating issue noted on the guidewire distal, mid or proximal sections.The patient¿s anatomy was moderately tortuous.The torsion issue was noted during the procedure when using guidewire to place the microcatheter to the place.Handling became worse.No other difficulties were encountered during the usage of the device that could have contributed to the issue.Product analysis found the guidewire distal end appeared to have been over-shaped similar to an ¿m¿ shape where the bends were noted 0.7cm and 1.2cm from the distal end.When the guidewire was hydrated, the distal shaft had a slight uneven swelling/bulge on its distal tip and traces of procedural fluid was evident.When dry after approximately 30 seconds, the swelling/bulge had disappeared.This is a cosmetic issue and there was no damage to the hydrophilic coating.During the dimensional inspection, they were confirmed to be within specification when the device was both wet and dry.During the functional inspection, difficulty was experienced inserting the guidewire through the flushed demonstration microcatheter hub due to the over-shaped distal end.Friction/resistance was experienced as the guidewire was advanced through the microcatheter.The torque device was not returned.As the root cause for the uneven swelling/bulge has not yet been established, an assignable cause of undeterminable will be assigned to the reported event of the guidewire torque problem in addition to the as analyzed damage of the device has cosmetic/appearance issue and guidewire friction.An assignable cause of procedural factors will be assigned to the analyzed damage of the guidewire distal end/tip kinked/bent and guidewire difficult to insert since this issue 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 and/or anatomical factors during use.There was evidence of scraping and peeling of the ptfe guidewire coating from the proximal end to 30.2cm from the proximal end.The peeling/scraping most likely occurred as a result of interaction with another device.The damage noted is consistent with backloading the proximal end of the guidewire into the distal end of the introducer and pulling it through the introducer.The analyzed damage of the guidewire ptfe coating peeling has been 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.

Event Description

The device was returned for analysis and the investigation of the device revealed that the guidewire (subject device) ptfe coating was peeling.No clinical consequences were reported to the patient due to this event.

• Brand Name: SYNCHRO-14 STRAIGHT 200-35CM
• Type of Device: 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: 17856812
• MDR Text Key: 324787681
• Report Number: 3012931345-2023-00216
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 07613252186922
• UDI-Public: 07613252186922
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K032146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M00313010
• Device Lot Number: 0000192100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Race: Asian