MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR XT-27 STD STRAIGHT 150CM; MICROCATHETER

Model Number M003XT2750810

Device Problems Fracture (1260); Material Puncture/Hole (1504)

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

Event Date 12/29/2020

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.Analysis of the returned subject microcatheter device found that the subject microcatheter device was flattened and kinked, there was a hole in the catheter shaft and the shaft was broken.The subject microcatheter device was flushed and the water exited through a hole in the catheter shaft.The reported defect was not confirmed during analysis however, the analysis results are consistent with the event.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 was no damage noted to the packaging prior to opening, the subject microcatheter device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, and the patient's anatomy was moderately tortuous.The damage noted to the subject microcatheter device would be indicative of the as reported defect.It was seen that the subject microcatheter device was flattened and kinked, there was a hole in the catheter shaft and the shaft was broken.The subject catheter most likely was damaged during the procedure due to some procedural/anatomical factors encountered during use leading to the reported and analysed defects.Based on the investigation results and available information, an assignable cause of procedural factors will be assigned to the as reported and as analyzed codes.

Event Description

Analysis of the returned subject device catheter revealed that the catheter shaft has hole/perforation and it was broken/fractured during use.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: EXCELSIOR XT-27 STD STRAIGHT 150CM
• Type of Device: MICROCATHETER
• 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: 11845254
• MDR Text Key: 251906671
• Report Number: 3008881809-2021-00211
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04546540698131
• UDI-Public: 04546540698131
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K113778
• 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: 05/18/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2022
• Device Model Number: M003XT2750810
• Device Catalogue Number: M003XT2750810
• Device Lot Number: 22005822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2019
• 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: 72 YR
• Patient Weight: 58