MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING CATHETER, PERCUTANEOUS

Model Number 24694

Device Problems Entrapment of Device (1212); Material Deformation (2976)

Patient Problems Hematoma (1884); Vomiting (2144)

Event Date 03/01/2021

Event Type  Injury  

Event Description

It was reported that device entrapment and removal difficulties were encountered. The patient also experienced vomiting and a hematoma. The 80-95% stenosed, 300mm, complex multilevel heavily calcified target lesion was located in the moderately tortuous femoral popliteal artery. A 6f non-boston scientific sheath and a 300cm, 8cm v-18 control wire were placed. A 4. 0 mm x 220 mm x 150 cm sterling balloon catheter was advanced for dilatation. The balloon was inflated thrice at 14 atmospheres for 2 minutes. The device was then fully deflated. The device was attempted to be removed off the wire. Removal difficulties were encountered. The hypotube of the sterling balloon catheter prolapsed and the hypotube kinked distally as a result from the removal difficulties. The physician removed the entire system intact along with the 6f sheath. It was also reported that the patient experienced a hematoma and vomiting. The physician performed a superficial femoral artery (sfa) recanalization and a computerized tomography scan (ct scan) was performed to rule out retroperitoneal hematoma (rph). The procedure was completed. The patient fully recovered.

• Brand Name: STERLING
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11507773
• MDR Text Key: 240439290
• Report Number: 2134265-2021-02874
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141150
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/27/2022
• Device Model Number: 24694
• Device Catalogue Number: 24694
• Device Lot Number: 0025944860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/17/2021 Patient Sequence Number: 1