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

Model Number	24700
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed, straight target lesion was located in a shunt in a non-calcified vein.An 8.0mmx40mmx40cm sterling balloon catheter was advanced for dilation.The balloon was inflated to 16 atmospheres.The balloon was removed due to rupture in the blood vessel.There was no patient injury.Upon withdrawal, the balloon was noted to be torn.The device fragment was removed surgically.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed, straight target lesion was located in a shunt in a non-calcified vein.An 8.0mmx40mmx40cm sterling balloon catheter was advanced for dilation.The balloon was inflated to 16 atmospheres.The balloon was removed due to rupture in the blood vessel.There was no patient injury.Upon withdrawal, the balloon was noted to be torn.The device fragment was removed surgically.
Additional Manufacturer Narrative
E1 initial reporter city: (b)(6).Device evaluated by mfr.: the device was returned for analysis.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast and blood in the inflation lumen and balloon.The balloon was loosely folded.Microscopic inspection revealed tip damage.There was a circumferential tear 3.5cm from the tip.There was a complete separation of the inner shaft 31.1cm distal of the strain relief.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10721428
• Report Number: 2134265-2020-14574
• Device Sequence Number: 3006361
• Product Code: DQY
• UDI-Device Identifier: 08714729720683
• UDI-Public: 08714729720683
• 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): 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/03/2020
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0021467156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 12/02/2020
• 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: GUIDEWIRE: TERUMO SHEATH WIRE; GUIDEWIRE: TERUMO SHEATH WIRE; INFLATION DEVICE: EVEREST; INFLATION DEVICE: EVEREST; INTRODUCER SHEATH: TERUMO 5F; INTRODUCER SHEATH: TERUMO 5F; GUIDEWIRE: TERUMO SHEATH WIRE; INFLATION DEVICE: EVEREST; INTRODUCER SHEATH: TERUMO 5F
• Outcome Attributed to Adverse Event: Required Intervention