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	10/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a new access site was created in order to deflate the balloon.An 8.0mm x 30mm x 80cm 4f sterling was selected for a percutaneous transluminal angioplasty procedure in the occluded arteriovenous shunt vessel.During the procedure, the balloon failed to fully deflate.While attempting to withdraw, the sterling could not be removed through the 4f non-boston scientific introducer sheath.The patient was punctured again and a retraction cannula was used to pierce and deflate the balloon.The sterling was removed from the sheath and the procedure was successfully completed.No patient complications were reported.
Event or Problem Description
It was reported that a new access site was created in order to deflate the balloon.An 8.0mm x 30mm x 80cm 4f sterling was selected for a percutaneous transluminal angioplasty procedure in the occluded arteriovenous shunt vessel.During the procedure, the balloon failed to fully deflate.While attempting to withdraw, the sterling could not be removed through the 4f non-boston scientific introducer sheath.The patient was punctured again and a retraction cannula was used to pierce and deflate the balloon.The sterling was removed from the sheath and the procedure was successfully completed.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of a sterling balloon catheter.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.There was a longitudinal tear 2mm long starting 7mm from the distal marker band consistent with the reported information that the balloon was punctured in order to deflate the device.The outer shaft was stretched down for 24.7cm starting 53.8cm from the hub.The inner shaft was separated from the manifold which is consistent with the tensile forces that also cause the stretched down outer shaft.The stretched outer shaft would have prevented the balloon from being able to deflate.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10727826
• Report Number: 2134265-2020-14636
• Device Sequence Number: 14317083
• Product Code: DQY
• UDI-Device Identifier: 08714729720669
• UDI-Public: 08714729720669
• 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): 11/12/2020

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: 05/06/2023
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0025495556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 11/12/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4F TERUMO RADIFOCUS INTRODUCER SHEATH; 4F TERUMO RADIFOCUS INTRODUCER SHEATH; 4F TERUMO RADIFOCUS INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Required Intervention