MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION V-18 CONTROL WIRE; WIRE, GUIDE, CATHETER

Model Number	40495
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.
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 evaluated by mfr: device returned and evaluated by manufacturer.Visual inspection: the guidewire was returned inside of a sterling balloon.The proximal end of the guidewire, approximately 54 cm, was out of the catheter.The section of wire found outside the catheter was in good condition, its surface was uniform and no kinks were observed.A section of the guidewire polymer jacket was found protruding the distal end of the sterling balloon; when it was slightly pulled, it got moved and it was discovered that it was detached from the guidewire.The detached section measured approximately 1 cm.Both ends of the polymer jacket were opened and some sections of it were flattened.Many attempts to remove the guidewire from the catheter were done, however, it was not possible to release it.No more visual damages were found in the device.Microscope inspection: detailed pictures of the affected area and the detached section were captured.Dimensional inspection: overall length: could not be performed due to device condition (guidewire stuck on catheter).Od of distal tip: could not be performed due to device condition (guidewire stuck on catheter).Od of middle of the device: could not be performed due to device condition (guidewire stuck on catheter).Od of proximal section: 0.0175 inches, within specification.

• Brand Name: V-18 CONTROL WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9729332
• Report Number: 2134265-2020-01698
• Device Sequence Number: 2101065
• Product Code: DQX
• UDI-Device Identifier: 08714729070184
• UDI-Public: 08714729070184
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K033742
• 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): 05/08/2020

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: 12/07/2020
• Device Model Number: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0023053267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2020
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 05/08/2020
• 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: FG STERLING OTW, 3.0X20X90 (4F); FG STERLING OTW, 3.0X20X90 (4F)