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

Model Number	24690
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon could not be withdrawn.The target lesion was located in the carotid artery.A 5.0mmx20mmx135cm sterling balloon catheter was selected for use.During the procedure, a non-bsc guidewire directed the balloon to the c6 segment, where it was released as planned.After the release, the balloon was retracted, but during the retraction, it became blocked and could not be fully withdrawn.The procedure was completed with another of the same device.There were no patient complications reported.The patient status was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual and microscopic examination revealed no damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found no damage that could have contributed to the difficulty to remove.
Event or Problem Description
It was reported that the balloon could not be withdrawn.The target lesion was located in the carotid artery.A 5.0mmx20mmx135cm sterling balloon catheter was selected for use.During the procedure, a non-bsc guidewire directed the balloon to the c6 segment, where it was released as planned.After the release, the balloon was retracted, but during the retraction, it became blocked and could not be fully withdrawn.The procedure was completed with another of the same device.There were no patient complications reported.The patient status was stable post procedure.It was further reported that the 85% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel.The balloon was deflated, and the non bsc guidewire and sterling device was removed together as one unit.

• 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: 19537037
• Report Number: 2124215-2024-35613
• Device Sequence Number: 8338020
• Product Code: DQY
• UDI-Device Identifier: 08714729757412
• UDI-Public: 08714729757412
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141150
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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 Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0033133889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2024
• 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
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 65 KG