MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 PRE-SHAPED 45 150CM; CATHETER, PERCUTANEOUS

Model Number	M0031681900
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes system (manufacturing execution system), there are controls in the manufacturing process to ensure the product met specifications upon release.Visual inspection revealed that the catheter shaft was seen to be flat/crushed approximately 1.3 cm from the distal tip.The catheter shaft was seen to be stretched and was seen to be kinked 68cm from the hub.The catheter secondary strain relief was seen to be flat/crushed 11cm from the hub.Functional inspection was performed as the catheter could not be flushed.An attempt was made to advance a 0.0158" patency mandrel through the catheter shaft but the mandrel would not advance past 11cm from the hub, so an attempt was made to advance the mandrel through the distal of the catheter but again the mandrel would not go past 66cm from the catheter tip.The catheter was then soaked in warm water and once removed the catheter was still found to be blocked, so in an attempt to figure out what was causing the blockage the catheter was cut just below the damaged area by the secondary strain relief and the mandrel advanced through again this time causing ptfe (polytetrafluoroethylene) inner lining to exit the catheter, further advancing of the mandrel through the other cut part of the catheter and some blood and procedural fluids also exited the catheter.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 indicated that there wasn't any damage noted to the packaging prior to opening and the device was confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was maintained throughout the clinical procedure.It was seen that the catheter shaft was kinked which would account for the difficulty advancing the coil.There was dried blood/procedural fluid within the catheter shaft.The ptfe inner lining most likely peeled due to the number of attempts were made inserting/advancing a patency mandrel and the coil.The catheter most likely kinked/bent during the procedure due to some procedural/anatomical factors encountered during use leading to the reported and analyzed defects.Based on the investigation results and available information, an assignable cause of procedural factors will be assigned to the catheter shaft friction, as well as the catheter shaft kinked/bent, catheter shaft flat/crushed, catheter shaft blocked/occluded, catheter ptfe inner lining peeling and catheter shaft stretched.
Event or Problem Description
Analysis of the returned subject and the ptfe (polytetrafluoroethylene) inner lining was observed.There was no clinical consequence to the patient due to this event.

• Brand Name: EXCELSIOR SL-10 PRE-SHAPED 45 150CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 14569930
• Report Number: 3008881809-2022-00260
• Device Sequence Number: 5041333
• Product Code: DQY
• UDI-Device Identifier: 04546540688224
• UDI-Public: 04546540688224
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K013789
• 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
• Report Date (Section B): 06/01/2022

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: 02/16/2023
• Device Model Number: M0031681900
• Device Catalogue Number: M0031681900
• Device Lot Number: 22749230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2021
• 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: 6F ENVOY GUIDE CATHETER; ATLAS STENT (STRYKER); SYNCHRO GUIDEWIRE (STRYKER); TARGET COILS (STRYKER)
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 69 KG
• Patient Race: Asian