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

Model Number	24700
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon was unable to deflate.A 7.0mm x 40mm x 80cm sterling balloon catheter was selected for a procedure in an arteriovenous shunt.The sterling was used with a non-boston scientific 4fr sheath and 0.018" guidewire.Balloon dilatation was performed twice.Deflation was unable to be performed with a dilatation syringe nor a 20ml syringe.Additional dilatation and deflation was attempted without success.The process was repeated using only saline versus the initial half saline half contrast mixture without success.The patient was punctured again and the sterling balloon catheter in the shunt was pierced from the outside with a cannula under fluoroscopy.The sheath was removed together with the balloon and guidewire.There were no patient complications and the patient was fine post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of an 0.018" guidewire stuck inside the 7.0mmx40mmx80cm sterling balloon catheter inside of a 4f sheath.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the inflation lumen was stretched from the proximal end of the balloon going proximally approximately 34.2cm.Microscopic examination revealed that the balloon has a longitudinal tear approximately 22mm from the tip and is approximately 2mm long.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the balloon was unable to deflate.A 7.0mmx40mmx80cm sterling balloon catheter was selected for a procedure in an arteriovenous shunt.The sterling was used with a non-boston scientific 4fr sheath and 0.018" guidewire.Balloon dilatation was performed twice.Deflation was unable to be performed with a dilatation syringe nor a 20ml syringe.Additional dilatation and deflation was attempted without success.The process was repeated using only saline versus the initial half saline half contrast mixture without success.The patient was punctured again and the sterling balloon catheter in the shunt was pierced from the outside with a cannula under fluoroscopy.The sheath was removed together with the balloon and guidewire.There were no patient complications and the patient was fine post procedure.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10843907
• Report Number: 2134265-2020-15885
• Device Sequence Number: 4246137
• Product Code: DQY
• UDI-Device Identifier: 08714729124108
• UDI-Public: 08714729124108
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K053116
• 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): 01/07/2021

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: 09/08/2023
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0025980045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 01/07/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.018" TERUMO GUIDEWIRE; 0.018" TERUMO GUIDEWIRE; 4FR TERUMO SHEATH; 4FR TERUMO SHEATH; 0.018" TERUMO GUIDEWIRE; 4FR TERUMO SHEATH
• Outcome Attributed to Adverse Event: Required Intervention