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	10/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified shunt.A 4.0mmx20mmx40cm sterling balloon catheter was advanced for dilatation.However, during first inflation at 12 atmospheres for 30 seconds, the balloon ruptured.The device was completely removed from the patient and the procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified shunt.A 4.0mmx20mmx40cm sterling balloon catheter was advanced for dilatation.However, during first inflation at 12 atmospheres for 30 seconds, the balloon ruptured.The device was completely removed from the patient and the procedure was completed with a different device.No patient complications were reported.Returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a pinhole 16mm from the tip.There is blood present in the inflation lumen and balloon.The balloon is loosely folded.Review of the product specification indicates the rated burst pressure (rbp) of the complaint device.The reported information indicates the device was inflated to 12 atm; therefore, there is no indication the device was inflated over rbp.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8087111
• Report Number: 2134265-2018-63038
• Device Sequence Number: 2017972
• Product Code: DQY
• UDI-Device Identifier: 08714729123538
• UDI-Public: 08714729123538
• 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): 12/07/2018

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: 02/27/2021
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0021805206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1