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

Model Number	24700
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.
Event or Problem Description
It was reported that balloon deflation issue, removal difficulties, and balloon rupture occurred.The 75% stenosed target lesion was located in the moderately tortuous and non-calcified left-hand shunt.An 8.0mmx40mmx80cm (4f) sterling balloon catheter was advanced for dilatation.However, when the device was removed from the sheath after the procedure, the distal tip of the balloon was not deflated, and the balloon was difficult to remove from the sheath.In spite of multiple inflation and deflation were performed to deflate the balloon, the balloon tip was not rewrapped; therefore, the balloon was inserted into the sheath, the balloon tip ruptured.Then, the balloon was successfully rewrapped and removed, and the procedure was completed.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.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 no damages.Microscopic examination revealed a pinhole 30mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found no damage that could have contributed to the failure to deflate or the difficulty to remove.
Event or Problem Description
It was reported that balloon deflation issue, removal difficulties, and balloon rupture occurred.The 75% stenosed target lesion was located in the moderately tortuous and non-calcified left-hand shunt.An 8.0mmx40mmx80cm (4f) sterling balloon catheter was advanced for dilatation.However, when the device was removed from the sheath after the procedure, the distal tip of the balloon was not deflated, and the balloon was difficult to remove from the sheath.In spite of multiple inflation and deflation were performed to deflate the balloon, the balloon tip was not rewrapped; therefore, the balloon was inserted into the sheath, the balloon tip ruptured.Then, the balloon was successfully rewrapped and removed, and the procedure was completed.There were no patient complications nor injuries reported.

• 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: 17299601
• Report Number: 2124215-2023-34196
• Device Sequence Number: 7009135
• Product Code: DQY
• UDI-Device Identifier: 08714729720690
• UDI-Public: 08714729720690
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2023

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: 10/23/2025
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0030409040
• 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: 06/22/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• 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 Sex: Male