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

Model Number	24700
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and mild calcified iliac.A 9.0mmx40mmx80cm (5f) sterling balloon catheter was advanced for dilatation.However, during second inflation at 14 atmospheres for 30 seconds, the balloon ruptured.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
E1 initial reporter city: (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, and inner/outer shaft included microscopic and visual inspection.Inspection revealed a burst in the balloon material that was 28mm in length, and balloon damage (zipper).Inspection of the rest of the device found no other damage or defect.
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and mild calcified iliac.A 9.0mmx40mmx80cm (5f) sterling balloon catheter was advanced for dilatation.However, during second inflation at 14 atmospheres for 30 seconds, the balloon ruptured.The procedure was completed with a different device.No patient complications were reported.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9910433
• Report Number: 2134265-2020-04229
• Device Sequence Number: 19671746
• Product Code: DQY
• UDI-Device Identifier: 08714729720799
• UDI-Public: 08714729720799
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K053116
• 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: 06/13/2021
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0022251430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 04/01/2020
• 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