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

Model Number	24700
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(6).Device evaluated by mfr: returned product consisted of a sterling balloon catheter.The length of balloon torn longitudinally.Microscopic examination of the balloon presented no irregularities in the balloon material or the ro marker that could have contributed to the damage.There was no other damage.There was no other damage revealed.The damage to the balloon is consistent with interaction with the lesion.
Event or Problem Description
Reportable based on the device analysis on 09jan2020.It was reported that inflation failure occurred.Vascular access was obtained via brachial approach.The 75% stenosed with large vessel diameter target lesion was located in the left subclavian vessel.A 10.0mmx40mmx80cm (5f) sterling balloon catheter was advanced for dilatation.However, the balloon was unable to inflate.The physician attempted to dilate the lesion by double balloon using two 7.0 x 40, 75cm mustang balloon catheters.However, during the first inflation at 18 atmospheres, one of the balloons ruptured.Both balloons were removed and the procedure was completed with 10mm sterling and 7mm mustang balloon catheters.There were no patient complications reported.However, returned device analysis revealed a longitudinal tear on the balloon.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9638324
• Report Number: 2134265-2020-00542
• Device Sequence Number: 11493832
• Product Code: DQY
• UDI-Device Identifier: 08714729123453
• UDI-Public: 08714729123453
• 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
• Report Date (Section B): 01/28/2020

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: 10/28/2021
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0022859760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1