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

Model Number	24700
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was unknown.Used first date of the month the event was reported.
Event or Problem Description
It was reported that the wire became stuck inside the balloon.A 200cm v-18 control wire and a 2.5mm x 60mm x 90cm sterling were selected for a procedure.While advancing the balloon on the guidewire, the guidewire became stuck inside the balloon.The device was removed.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned device consisted of a sterling balloon catheter with a guide wire inside the device.There was fluid in the shaft and balloon.The balloon was loosely folded.110 cm of the guide wire was protruding out of the catheter hub, and the guide wire was removed from the sterling catheter during analysis.Analysis of the tip, balloon, inner/outer shaft, and hub included visual and microscopic inspection.Inspection revealed the inner shaft was stretched and split open starting 55mm from the tip of the device.No other damage or defect was found with the returned device.The wire used with the device was used for device-to-device testing.The proximal end of the guide wire was inserted into the tip of the sterling catheter and was able to advance 60mm, then stopped inside the inner shaft damage and could not advance any further.The inner diameter (id) of the device was measured and met the product specification.The guide wire was measured with a calibrated micrometer and was less than.018" meeting specification.
Event or Problem Description
It was reported that the wire became stuck inside the balloon.A 200cm v-18 control wire and a 2.5mm x 60mm x 90cm sterling were selected for a procedure.While advancing the balloon on the guidewire, the guidewire became stuck inside the balloon.The device was removed.No patient complications were reported.It was further reported that this was a recanalization procedure for an occlusion in the leg.A 2.5mm x 120mm x 90cm sterling was used to complete the procedure.
Event or Problem Description
It was reported that the wire became stuck inside the balloon.A 200cm v-18 control wire and a 2.5mm x 60mm x 90cm sterling were selected for a procedure.While advancing the balloon on the guidewire, the guidewire became stuck inside the balloon.The device was removed.No patient complications were reported.It was further reported that this was a recanalization procedure for an occlusion in the leg.A 2.5mm x 120mm x 90cm sterling was used to complete the procedure.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10755966
• Report Number: 2134265-2020-14998
• Device Sequence Number: 14419284
• Product Code: LIT
• UDI-Device Identifier: 08714729860068
• UDI-Public: 08714729860068
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 12/16/2020

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: 12/01/2020
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0023904254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2020
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 11/13/2020; 12/15/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 11/25/2020; 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1