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	10/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in the posterior tibial artery.A 300cm, 8cm poly tip v-18 control wire was advanced to the lesion.A 4.0mmx20mmx135cm (4f) sterling balloon catheter was selected for dilatation.When the device was flushed and advanced half-way, it was noted that it was stuck on the wire.Both devices were removed together and the procedure was completed with different devices.No patient complications nor injuries were reported and the patient's status was fine.
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in the posterior tibial artery.A 300cm, 8cm poly tip v-18 control wire was advanced to the lesion.A 4.0mmx20mmx135cm (4f) sterling balloon catheter was selected for dilatation.When the device was flushed and advanced half-way, it was noted that it was stuck on the wire.Both devices were removed together and the procedure was completed with different devices.No patient complications nor injuries were reported and the patient's status was fine.Returned device consisted of a sterling balloon catheter with the related v-18 guide wire firmly stuck in the inner shaft/lumen.The balloon was loosely folded and there was fluid in the inflation lumen.The tip, balloon, markerband, and inner/outer shafts(lumens) were microscopically and visually inspected.Inspection revealed that the inner shaft was pulled out from the manifold for a length of 9.5 cm, inner shaft damaged (buckled) for a length of 15 cm, outer shaft damage (buckling) at the strain relief for a length of 6 mm, inner and outer shaft damage (stretched/ necked down) for a length of 12.5 cm located near the proximal end of the device.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The device was received with 70.5 cm of the guide wire protruding out of the sterling hub, and 73.5 cm protruding from the tip.The proximal end of the guide wire was damaged (numerous bends).Functional testing could not be performed as the guide wire could not be removed from the catheter, so the device was x-rayed to check for any wire/catheter defects.X-ray found no damage or irregularities.
Additional Manufacturer Narrative
This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/17/2018 11:55 am ct.The report number is being corrected from: 2134265-2018-64140 to: 2134265-2018-62813.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8065451
• Report Number: 2134265-2018-62813
• Device Sequence Number: 14011622
• Product Code: DQY
• UDI-Device Identifier: 08714729123521
• UDI-Public: 08714729123521
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K053116
• 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): 01/24/2019

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: 07/11/2020
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0020876163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1