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

Model Number	24716
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The totally occluded target lesion was located in the mildly tortuous and severely calcified superficial femoral artery and below the knee vessel.A 2.0x220x150 (4f) sterling balloon catheter was advanced for dilatation.However, during inflation at nominal atmospheres, the balloon ruptured.The device was simply pulled out and completely removed.The procedure was completed with another of the same device.No patient complications were reported and the patient was fine.
Event or Problem Description
It was reported that balloon rupture occurred.The totally occluded target lesion was located in the mildly tortuous and severely calcified superficial femoral artery and below the knee vessel.A 2.0x220x150 (4f) sterling balloon catheter was advanced for dilatation.However, during inflation at nominal atmospheres, the balloon ruptured.The device was simply pulled out and completely removed.The procedure was completed with another of the same device.No patient complications were reported and the patient was fine.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).Device evaluated by mfr.: returned device consisted of a sterling balloon catheter.The balloon was loosely folded and bloody.Analysis of the tip, balloon, inner/outer shaft, exit notch/port weld and hypotube included microscopic and visual inspection.Inspection revealed a pinhole in the balloon material that was 81mm from the tip of the device.Inspection of the rest of the device found no other damage or defect.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9878812
• Report Number: 2134265-2020-03834
• Device Sequence Number: 16939742
• Product Code: LIT
• UDI-Device Identifier: 08714729859970
• UDI-Public: 08714729859970
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K141112
• 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
• Report Date (Section B): 04/27/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/03/2021
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0024713042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 04/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR