MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24703
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in the severely tortuous and severely calcified anterior tibial artery.A 2.0mm x 150mm x 90cm sterling sl balloon catheter was advanced for dilatation.However, during advancing, the balloon catheter became stuck on the guide wire.Both balloon catheter and guide wire were then removed simultaneously from the patient's body.The procedure was discontinued due to another reason.No complications were reported and the patient's condition was good.
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in the severely tortuous and severely calcified anterior tibial artery.A 2.0mm x 150mm x 90cm sterling sl balloon catheter was advanced for dilatation.However, during advancing, the balloon catheter became stuck on the guide wire.Both balloon catheter and guide wire were then removed simultaneously from the patient's body.The procedure was discontinued due to another reason.No complications were reported and the patient condition was good.Returned product consisted of a sterling sl balloon catheter with a victory.018 guidewire.The guidewire was received separately and not in the shaft of the sterling sl catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen and balloon.The balloon was loosely folded.There was numerous buckling of the outer and inner shafts throughout the shaft of the device.The tip was damaged.The victory guidewire used in the procedure was returned for analysis with this complaint device, so it was used for functional testing.The wire was inserted into the tip and advance; however, the wire would not track past the damaged shaft.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: STERLING SL
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7870582
• Report Number: 2134265-2018-60913
• Device Sequence Number: 11221492
• Product Code: DQY
• UDI-Device Identifier: 08714729782414
• UDI-Public: 08714729782414
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K093720
• 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: 01/30/2020
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0021679984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 09/12/2018
• 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