MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRA-SOFT SV; CATHETER, PERCUTANEOUS

Model Number 24680

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/21/2019

Event Type  malfunction  

Event Description

It was reported that a device was incorrectly labeled.During a carotid stenting procedure, a 2.0 mm x 30mm x 143cm ultra soft sv was noticed to have an incorrect label.The label on the outside packaging was for a 3.0 mm x 20mm x 143cm ultra soft sv device (lot number 22772605).The procedure was completed successfully.No patient complications were reported in relation to this event.

Event Description

It was reported that a device was incorrectly labeled.During a carotid stenting procedure, a 2.0 mm x 30mm x 143cm ultra soft sv was noticed to have an incorrect label.The label on the outside packaging was for a 3.0 mm x 20mm x 143cm ultra soft sv device (lot number 22772605).The procedure was completed successfully.No patient complications were reported in relation to this event.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an ussv (ultrasoft) balloon catheter.The device was sealed in the pouch, with the pouch inside the shelf carton.The shelf carton tear tab was opened.The hub, pouch and shelf carton were microscopically and visually inspected.Inspection revealed the printing on the hub stated the size of the device to be ussv 2.0/3.0 with the printing on the pouch and shelf carton to be 3.0x2.0.Inspection of the rest of the device found no other damage or irregularities.The incorrect printing (size on hub) was confirmed.

• Brand Name: ULTRA-SOFT SV
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8429973
• MDR Text Key: 139117675
• Report Number: 2134265-2019-02492
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2021
• Device Model Number: 24680
• Device Catalogue Number: 24680
• Device Lot Number: 22772605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Date Manufacturer Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1