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

Model Number	24700
Medical Device Problem Codes	Break (1069); Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that failure to deflate, removal difficulties, and shaft break were encountered.The 75% stenosed target lesion was located in the non-tortuous and non-calcified external iliac artery.A 5.0mmx80mmx135cm (4f) sterling balloon catheter was advanced for dilatation; however, during the procedure, the balloon did not fully deflate.Upon withdrawal, the device got stuck within the sheath and the balloon shaft broke.The partially inflated balloon was pulled out through the sheath along with the guidewire.No patient complications were reported and the patient condition was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling balloon catheter.The device was microscopically and visually examined.The shaft of the device has multiple stretched down areas and kinks.The total length of stretched down shaft areas were approximately 100cm.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was loosely folded, and the device also had a pinched tip.There was a separation 13.4cm proximal to the distal (tip) portion of the device.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported break as there was separation to the device.The device also had numerous kinks to the shaft.
Event or Problem Description
It was reported that failure to deflate, removal difficulties, and shaft break were encountered.The 75% stenosed target lesion was located in the non-tortuous and non-calcified external iliac artery.A 5.0mmx80mmx135cm (4f) sterling balloon catheter was advanced for dilatation; however, during the procedure, the balloon did not fully deflate.Upon withdrawal, the device got stuck within the sheath and the balloon shaft broke.The partially inflated balloon was pulled out through the sheath along with the guidewire.No patient complications were reported and the patient condition was fine.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11570872
• Report Number: 2134265-2021-03299
• Device Sequence Number: 3599278
• Product Code: DQY
• UDI-Device Identifier: 08714729122951
• UDI-Public: 08714729122951
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K053116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2021

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: 11/01/2021
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0022881473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1