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

Model Number 24690

Device Problem Material Rupture (1546)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 08/14/2020

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred and the patient was sent to surgery.The target lesion was located in the carotid artery.A 4.0mmx30mmx135cm (4f) sterling balloon catheter was advanced for pre-dilatation.However, during inflation, the balloon ruptured.The patient was then sent to surgery.The procedure was completed with another of the same device.There were no additional patient complications reported.

Event Description

It was reported that balloon rupture occurred and the patient was sent to surgery.The target lesion was located in the carotid artery.A 4.0mmx30mmx135cm (4f) sterling balloon catheter was advanced for pre-dilatation.However, during inflation, the balloon ruptured.The patient was then sent to surgery.The procedure was completed with another of the same device.There were no additional patient complications reported.It was further reported that the balloon was inflated once before it ruptured.It was corrected that the patient did not have surgical intervention due to the event.The patient was in stable condition post procedure completion and had left the hospital.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a sterling balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast and blood in the inflation lumen.The balloon was loosely folded.There was a longitudinal tear 24mm long starting 6mm from the proximal marker band.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that balloon rupture occurred and the patient was sent to surgery.The target lesion was located in the carotid artery.A 4.0mmx30mmx135cm (4f) sterling balloon catheter was advanced for pre-dilatation.However, during inflation, the balloon ruptured.The patient was then sent to surgery.The procedure was completed with another of the same device.There were no additional patient complications reported.It was further reported that the balloon was inflated once before it ruptured.It was corrected that the patient did not have surgical intervention due to the event.The patient was in stable condition post procedure completion and had left the hospital.

• Brand Name: STERLING
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10442290
• MDR Text Key: 204014761
• Report Number: 2134265-2020-11559
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729756972
• UDI-Public: 08714729756972
• Combination Product (y/n): N
• PMA/PMN Number: K141150
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2023
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0025018348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Date Manufacturer Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 92 YR
• Patient Weight: 72