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

Model Number	24700
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that slow deflation occurred.A 3.0 x 20 x 90 (4f) sterling was advanced to the target lesion.While trying to remove the device, the balloon had an extremely long deflation time.The procedure was completed with this device.No patient complications were reported in relation to this event.
Event or Problem Description
It was reported that slow deflation occurred.A 3.0 x 20 x 90 (4f) sterling was advanced to the target lesion.While trying to remove the device, the balloon had an extremely long deflation time.The procedure was completed with this device.No patient complications were reported in relation to this event.Returned product consisted of a sterling balloon catheter.The shaft, hypotube, balloon, bonds and tip were microscopically and visually examined.The balloon was loosely folded and deflated, when received.There was no damage or irregularities to the device.Functional testing was performed with an inflation device filled with water that was connected to the inflation lumen.The device was inflated to the rated burst pressure.The catheter maintained constant pressure and there was no indication of any leaks or other anomalies.After confirming the device maintained rbp, the device was deflated by applying negative pressure with the inflation device and the balloon deflated instantly with no issues or air left in the balloon.Inspection of the device presented no damage or irregularities.Product analysis did not confirm the reported event.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7866411
• Report Number: 2134265-2018-60772
• Device Sequence Number: 1678189
• Product Code: LIT
• UDI-Device Identifier: 08714729860105
• UDI-Public: 08714729860105
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2018

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: 06/20/2019
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0021545036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1