MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 24703

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2020

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The target lesion was located in the left popliteal artery.After ivus was performed, a 4.0mm x 150mm x 150cm sterling balloon catheter was advanced for dilation.However, during inflation at 4 atmospheres the balloon ruptured and would not inflate further.The device was removed and the patient condition was stable and unharmed.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a sterling sl balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast and blood in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.Microscopic inspection revealed tip damage.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a longitudinal tear 1mm long starting 53mm from the distal marker band.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported balloon ruptured.

Event Description

It was reported that balloon rupture occurred.The target lesion was located in the left popliteal artery.A 4.0mm x 150mm x 150cm sterling balloon catheter was selected for use.The balloon was tracked appropriately over the wire to target in the popliteal artery.The balloon was inflated at 4 atmospheres when it burst and would not inflate further.

• Brand Name: STERLING SL
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10608258
• MDR Text Key: 209236292
• Report Number: 2134265-2020-13548
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729782384
• UDI-Public: 08714729782384
• Combination Product (y/n): N
• PMA/PMN Number: K093720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2022
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0025729980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1