MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO PRO 14 MICROCATHETER 157CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 90231

Device Problem Fracture (1260)

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

Event Date 12/08/2021

Event Type  malfunction  

Manufacturer Narrative

Device discarded at hospital.

Event Description

It was reported that the subject catheter was broken during the medical procedure.The procedure was completed successfully with no clinical consequences to the patient.

Manufacturer Narrative

H4 manufacturing date ¿ added.D4 expiration date - added.Due to the automated dhr system there are controls in the manufacturing process to ensure the product met specifications upon release.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 reported complaint could not be confirmed and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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 and continuous flush was set up and maintained throughout the clinical procedure.Also additional information received indicated that the device was not prepared as per the dfu therefore the complaint will be assigned user error.The device should have been prepared for use as per dfu, an assignable cause of user error will be assigned.H3 other text : device discarded at hospital.

Event Description

It was reported that the subject catheter was broken during the medical procedure.The procedure was completed successfully with no clinical consequences to the patient.

• Brand Name: TREVO PRO 14 MICROCATHETER 157CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: 13065412
• MDR Text Key: 282696363
• Report Number: 3012931345-2021-00221
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00815742002317
• UDI-Public: 00815742002317
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K113260
• 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: 04/18/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2023
• Device Model Number: 90231
• Device Catalogue Number: 90231
• Device Lot Number: 0000059218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 03/22/2022
• Supplement Dates FDA Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2021
• 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