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	03/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that catheter entrapment on the guidewire occurred.Vascular access was gained with antegrade approach.The 80 percent stenosed lesion was located in the moderately calcified and normally tortuous anterior tibialis artery in the lower leg.A non-bsc sheath was placed.A 20/300 v-18 control wire was advanced.A 2.0x40x150 (4f) sterling balloon catheter was introduced over the guidewire.The stenosis was dilated with the sterling balloon.After successful dilation, an attempt to pull back the balloon was made; however this was not possible.The balloon and the guidewire were pulled out of the patient together.The procedure was considered completed.No patient complications reported and the patient's status was okay.
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).Device evaluated by mfr: received product consisted of a sterling otw balloon catheter.The balloon was loosely folded with contrast in the balloon and inflation lumen (inner shaft), and blood in the wire lumen.The device was placed in a warm water bath for 1 hour.The wire used in the procedure was not returned for analysis.Based on the potential root causes identified, the tip, balloon, inner/outer shafts, and hypotube were microscopically and visually inspected.Inspection revealed tip damage (flared).Inspection of the rest of the device found no other damage or defect.Functional testing was conducted with a lab supplied.014 inch and.018 inch guide wire.After removing the blood from the inner lumen (shaft), both guide wires were loaded into the tip of the device and exited, without issue, through the port/exit notch.Review of the product specification indicates the sterling is compatible with a.018 inch guide wire.The reported information indicates the sterling was used with a v-18 guide wire; therefore, there is no indication of a compatibility issue.The reported guide wire difficulty was not confirmed.
Event or Problem Description
It was reported that catheter entrapment on the guidewire occurred.Vascular access was gained with antegrade approach.The 80 percent stenosed lesion was located in the moderately calcified and normally tortuous anterior tibialis artery in the lower leg.A non-bsc sheath was placed.A 20/300 v-18 control wire was advanced.A 2.0x40x150 (4f) sterling balloon catheter was introduced over the guidewire.The stenosis was dilated with the sterling balloon.After successful dilation, an attempt to pull back the balloon was made; however this was not possible.The balloon and the guidewire were pulled out of the patient together.The procedure was considered completed.No patient complications reported and the patient's status was okay.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8516303
• Report Number: 2134265-2019-03904
• Device Sequence Number: 11233659
• Product Code: LIT
• UDI-Device Identifier: 08714729859932
• UDI-Public: 08714729859932
• 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): 06/05/2019

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: 06/30/2020
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0023130409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1