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

Model Number 24715

Device Problem Material Rupture (1546)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: used the first date of the month of the aware date as no event date was provided.

Event Description

It was reported that balloon rupture occurred.A 5.0x150x150-hybrid sterling balloon catheter was advanced for dilation; however, during inflation at 12 atmospheres, the balloon ruptured.No known patient complications were reported.

Manufacturer Narrative

B3 date of event updated.B5 describe event or problem updated.E1 initial reporter title updated.E1 initial reporter last name updated.

Event Description

It was reported that balloon rupture occurred.A 5.0x150x150-hybrid sterling balloon catheter was advanced for dilation; however, during inflation at 12 atmospheres, the balloon ruptured.No known patient complciations were reported.It was further reported that the 60% stenosed target lesion was located in the moderately calcified and non-tortuous popliteal artery.Previously, it was reported that the balloon ruptured at 12 atmospheres.Now, it is reported that it ruptured at 13 atmospheres.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed a longitudinal tear in the balloon 38mm from the tip and is approximately 48mm long.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that balloon rupture occurred.A 5.0x150x150-hybrid sterling balloon catheter was advanced for dilation; however, during inflation at 12 atmospheres, the balloon ruptured.No known patient complciations were reported.It was further reported that the 60% stenosed target lesion was located in the moderately calcified and non-tortuous popliteal artery.Previously, it was reported that the balloon ruptured at 12 atmospheres.Now, it is reported that it ruptured at 13 atmospheres.

• Brand Name: STERLING
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11433608
• MDR Text Key: 238349461
• Report Number: 2134265-2021-02924
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729845362
• UDI-Public: 08714729845362
• Combination Product (y/n): N
• PMA/PMN Number: K132430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2021

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: 03/23/2022
• Device Model Number: 24715
• Device Catalogue Number: 24715
• Device Lot Number: 0026069993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/08/2021
• Supplement Dates Manufacturer Received: 03/11/2021; 04/01/2021
• Supplement Dates FDA Received: 03/22/2021; 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1