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

Model Number	24716
Medical Device Problem Codes	Deflation Problem (1149); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon was slow to deflate.The target lesion was approximately 65% stenosed and located in the mildly tortuous and mildly calcified superficial femoral artery.After placing a 6fr 45cm non-boston scientific (bsc) sheath, a 014 thruway guidewire was advanced into the tibial branches.The target lesion was treated with laser atherectomy followed with angioplasty using a 7.0x220150-hybrid sterling balloon catheter.The balloon was prepped normally and advanced over the wire without any difficulty.The balloon was inflated to nominal pressure and then taken to burst pressure.However, during inflation, it was noted that a part of the balloon would not inflate.The pressure was not held long due to the visual "filling" defect on the balloon.During withdrawal, the physician had to work the balloon inflator back and forth.The balloon took over 2 minutes to deflate and was pulled out over the wire.The procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
The device was returned for evaluation.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the balloon has a twist 6cm from the tip.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found a twist in the balloon.

• 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: 18311814
• Report Number: 2124215-2023-66503
• Device Sequence Number: 6626356
• Product Code: LIT
• UDI-Device Identifier: 08714729845560
• UDI-Public: 08714729845560
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K132430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2023

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: 07/06/2026
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0031964460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2023
• 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: GUIDEWIRE: 014 THRUWAY.; INTRODUCER SHEATH: 6FR 45CM DESTINATION.
• Patient Sex: Unknown