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

Model Number	24690
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	08/14/2020
Type of Reportable Event	Malfunction
Event or Problem 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10442290
• Report Number: 2134265-2020-11559
• Device Sequence Number: 16822792
• Product Code: DQY
• UDI-Device Identifier: 08714729756972
• UDI-Public: 08714729756972
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141150
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 08/25/2020; 10/19/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 09/01/2020; 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 72