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	02/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon became stuck on the wire.A sterling over-the-wire, 3.0mm x 20mm 90cm 4 french (4f) balloon along with a v-18, 150cm, 8cm poly tip guidewire were selected for a percutaneous transluminal angioplasty (pta) procedure.During the procedure, the wire was positioned in the patient and the balloon was passed over the wire with no problem and the balloon successfully inflated.Upon removal attempts, when the physician attempted to slide the balloon back along the wire it would not move and was stuck on the wire.The wire and balloon were removed from the patient together.No known patient complications were reported.
Additional Manufacturer Narrative
Device eval by manufacturer? returned product consisted of a sterling balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.Microscopic inspection revealed tip damage.There was a guidewire stuck in the device.The inner shaft was buckled 56mm from the tip.The device was soaked in a water bath for two days to loosen the blood and contrast in the device.The guidewire was not able to be removed from the device.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the balloon became stuck on the wire.A sterling over-the-wire, 3.0mm x 20mm 90cm 4 french (4f) balloon along with a v-18, 150cm, 8cm poly tip guidewire were selected for a percutaneous transluminal angioplasty (pta) procedure.During the procedure, the wire was positioned in the patient and the balloon was passed over the wire with no problem and the balloon successfully inflated.Upon removal attempts, when the physician attempted to slide the balloon back along the wire it would not move and was stuck on the wire.The wire and balloon were removed from the patient together.No known 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: 9729416
• Report Number: 2134265-2020-01695
• Device Sequence Number: 2295531
• Product Code: LIT
• UDI-Device Identifier: 08714729860105
• UDI-Public: 08714729860105
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K141112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2020

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: 06/11/2020
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0023083029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 04/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: V-18, 150CM, 8CM POLY TIP; V-18, 150CM, 8CM POLY TIP