MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING; CATHETER, PERCUTANEOUS

Model Number	24700
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years and older.
Event or Problem Description
It was reported that removal difficulties and balloon deflation failure occurred and foreign object was noted on the device.The 80% stenosed target lesion was an area of in-stent restenosis (isr) of an unknown stent located in the moderately tortuous and mildly calcified subclavian vein.A 8.0mmx40mmx80cm (4f) sterling balloon catheter was advanced for in-stent dilatation.The lesion was dilated three times at 12 atmospheres each inflation.However, after the 3rd dilatation, deflation failure occurred.Fluoroscopy revealed a foreign object in the present inside the balloon.When the balloon was moved, the foreign object moved together with it.While waiting to apply negative pressure, the balloon gradually deflated and it was slowly removed from the sheath.Upon removal, there was no rupture issue and no separation was noted.The lesion was dilated successfully and the procedure was completed.No patient serious injury nor adverse events were reported.
Event or Problem Description
It was reported that removal difficulties and balloon deflation failure occurred and foreign object was noted on the device.The 80% stenosed target lesion was an area of in-stent restenosis (isr) of an unknown stent located in the moderately tortuous and mildly calcified subclavian vein.A 8.0mmx40mmx80cm (4f) sterling balloon catheter was advanced for in-stent dilatation.The lesion was dilated three times at 12 atmospheres each inflation.However, after the 3rd dilatation, deflation failure occurred.Fluoroscopy revealed a foreign object in the present inside the balloon.When the balloon was moved, the foreign object moved together with it.While waiting to apply negative pressure, the balloon gradually deflated and it was slowly removed from the sheath.Upon removal, there was no rupture issue and no separation was noted.The lesion was dilated successfully and the procedure was completed.No patient serious injury nor adverse events were reported.
Additional Manufacturer Narrative
Age at time of event: 18 years and older.Device evaluated by mfr.: returned product consisted of a sterling mr balloon catheter, an unknown guide wire and an introducer sheath.The balloon was loosely folded and partially inflated with fluid.The device was soaked in a warm water bath for 5 days.The tip, balloon, markerbands, proximal bond, and inner/outer shaft were microscopically and visually inspected.Inspection revealed a complete separation in the inner shaft (lumen) located 10.8cm from the tip of the device, balloon damage (bunching) at both distal and proximal ends, inner and outer shaft damaged (stretched/necked) for a length of 16.4 cm.Inspection of the remaining device found no other damage or irregularities.Functional testing consisted of attaching an inflation device (filled with water) to the hub of the sterling device and applying positive pressure.While pressure was applied to the device, the fluid could not flow into the balloon, due to the stretched shaft.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8560734
• Report Number: 2134265-2019-04127
• Device Sequence Number: 1836241
• Product Code: DQY
• UDI-Device Identifier: 08714729720690
• UDI-Public: 08714729720690
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K053116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2019

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: 11/15/2021
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0022951709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 05/22/2019
• 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: GUIDE WIRE: 150CM FUGA; GUIDE WIRE: 150CM FUGA; INFLATION DEVICE: NIPRO GM3 0F; INFLATION DEVICE: NIPRO GM3 0F; INTRODUCER SHEATH: 5FR VAIVT ACE; INTRODUCER SHEATH: 5FR VAIVT ACE