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

Model Number	24700
Medical Device Problem Codes	Material Rupture (1546); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent surgery.The target lesion was located in a mildly tortuous and calcified vessel.An 8.0mmx40mmx135cm (4f) sterling balloon catheter was advanced to treat a peripheral vascular disease.The device was prepared and inserted as per instructions for use and the balloon was inflated with encore 26 inflation device over the lesion.When negative pressure was applied to deflate the device, the balloon would not fully deflate.The balloon was attempted to deflate multiple times with no success.The physician then tried to dilute 50% contrast and 50% saline solution with a higher concentration of saline, however, the deflation issue was not resolved.The physician then pulled the partially deflated balloon to the distal end of the sheath inside the patient's body and tried to pull the balloon against the sheath to try to deflate the balloon further, but still did not work.As there was no other way, the physician then decided to burst the balloon.The balloon burst fragments was dislodged from the balloon catheter and were left inside the patient's artery.The physician performed surgical procedure to cut down the blood vessel to remove the balloon fragments.No further complications were reported, and the patient is expected to fully recover.
Event or Problem Description
It was reported that the patient underwent surgery.The target lesion was located in a mildly tortuous and calcified vessel.An 8.0mmx40mmx135cm (4f) sterling balloon catheter was advanced to treat a peripheral vascular disease.The device was prepared and inserted as per instructions for use and the balloon was inflated with encore 26 inflation device over the lesion.When negative pressure was applied to deflate the device, the balloon would not fully deflate.The balloon was attempted to deflate multiple times with no success.The physician then tried to dilute 50% contrast and 50% saline solution with a higher concentration of saline, however, the deflation issue was not resolved.The physician then pulled the partially deflated balloon to the distal end of the sheath inside the patient's body and tried to pull the balloon against the sheath to try to deflate the balloon further, but still did not work.As there was no other way, the physician then decided to burst the balloon.The balloon burst fragments was dislodged from the balloon catheter and were left inside the patient's artery.The physician performed surgical procedure to cut down the blood vessel to remove the balloon fragments.No further complications were reported, and the patient is expected to fully recover.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the shaft and multiple stretching to the shaft.The guidewire lumen is separated into 3 pieces.The proximal piece is separated 140.5cm from the hub.The middle piece is still inside the proximal end of the inflation lumen and measures approximately 10.7cm long.The distal end of the guidewire lumen is separated 4mm from the tip.The inflation lumen is separated 154.3cm from the hub and appears to have been separated at the balloon to shaft bond joint.Microscopic examination revealed damage to the tip.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; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18506960
• Report Number: 2124215-2023-75964
• Device Sequence Number: 12750202
• Product Code: DQY
• UDI-Device Identifier: 08714729720676
• UDI-Public: 08714729720676
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2024

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: 07/24/2026
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0032080480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2023
• Supplement Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INFLATION DEVICE: ENCORE 26; INFLATION DEVICE: ENCORE 26
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown