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

Model Number 24716

Device Problems Deflation Problem (1149); Material Deformation (2976)

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

Event Date 03/30/2022

Event Type  malfunction  

Event Description

It was reported that balloon deflation failure occurred. The 95% stenosed target lesion was located in the mildly tortuous and mildly calcified anterior tibial artery. A 3. 0x220x90 (4f) sterling balloon catheter was advanced for dilatation. During the procedure, the balloon was inflated at 6 atmospheres for 1 minute; however, the balloon would not deflate. Tried double negative with the 3way and a 30cc attached as well. Tried a stiffer wire and eventually, was able to move the balloon enough to deflate some. The device was removed partially inflated from the patient and a kink was noticed on the device. The procedure was completed with another of same device. There were no patient complications 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: 14187111
• MDR Text Key: 289884258
• Report Number: 2134265-2022-04070
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/22/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0028887465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial