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

Model Number 24690

Device Problems Material Rupture (1546); Material Twisted/Bent (2981)

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

Event Date 02/07/2022

Event Type  malfunction  

Event Description

It was reported that balloon pinhole occurred. The 95% stenosed, 6mm target lesion was located in the moderately tortuous and severely calcified superficial femoral artery. Pre-inflation was performed with a 3mm balloon. After the non-boston scientific guidewire was crossed to the lesion, a 5. 0mmx220mmx150cm (4f) sterling balloon catheter was advanced for dilatation. However, during the first inflation at 10 atmospheres for 30 seconds, the balloon twisted. The device was removed. In an attempt to fix the twisted balloon outside of the patient, the guidewire was advanced in and out of the balloon resulting in the guidewire penetrating through the balloon. The procedure was completed with a different device. There were no patient complications nor injuries reported.

Manufacturer Narrative

Initial reporter city: (b)(6).

Manufacturer Narrative

Initial reporter city: (b)(6).

Event Description

It was reported that balloon pinhole occurred. The 95% stenosed, 6mm target lesion was located in the moderately tortuous and severely calcified superficial femoral artery. Pre-inflation was performed with a 3mm balloon. After the non-boston scientific guidewire was crossed to the lesion, a 5. 0mmx220mmx150cm (4f) sterling balloon catheter was advanced for dilatation. However, during the first inflation at 10 atmospheres for 30 seconds, the balloon twisted. The device was removed. In an attempt to fix the twisted balloon outside of the patient, the guidewire was advanced in and out of the balloon resulting in the guidewire penetrating through the balloon. The procedure was completed with a different device. There were no patient complications nor injuries reported.

• 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: 13599266
• MDR Text Key: 286138041
• Report Number: 2134265-2022-02030
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K141150
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0028176826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2021
• 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: 02/25/2022 Patient Sequence Number: 1

Treatment

GUIDEWIRE USED: CRUISE; INTRODUCER SHEATH USED: DESTINATION 6F