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 08/03/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : the device is not available to the manufacturer.

Event Description

It was reported that during left mca stenosis procedure, when the subject guidewire was delivered to the microcatheter the ptfe (polytetrafluoroethylene) coating was peeled from the middle section.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

Manufacturer Narrative

H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.D10 product available to stryker ¿ updated.D10 returned to manufacturer on ¿updated.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the guidewire was noted o be slightly kinked from the proximal end of the guidewire.The guidewire ptfe (polytetrafluoroethylene) coating was seen to be peeling from the proximal end of the guidewire.The core wire distal end was observed through the distal tip dome.Functional inspection was not applicable as visual defect was confirmed during analysis.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 confirmed based on the damage noted to the returned device.The device failed to meet specification when returned for analysis.It was reported that when delivered the guidewire with the microcatheter, the operator found large area of the coating at middle of the guidewire peeled off.Additional information indicates there was the device was confirmed to be in good condition during preparation/prior to use on the patient.The introducer sheath was not used with the guidewire during the insertion process.The torque device was used with the guidewire.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.An assignable cause of handling damage has been assigned to the as reported and as analyzed 'guidewire ptfe coating peeling' and to the analyzed ¿guidewire kinked/bent¿ 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

It was reported that during left mca stenosis procedure, when the subject guidewire was delivered to the microcatheter the ptfe (polytetrafluoroethylene) coating was peeled from the middle section.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• 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: 17600087
• MDR Text Key: 321736097
• Report Number: 3012931345-2023-00195
• 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,Followup
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• 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: 0000175067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2022
• 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
• Treatment: EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Race: Asian