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

Model Number	H74939031502010
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility: (b)(6) hospital.
Event or Problem Description
It was reported that balloon deflation slow and difficulty removal occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified internal carotid artery and common carotid artery.A 5.0mmx20mmx135cm (4f) sterling balloon catheter was advanced for dilatation.During procedure, the balloon was successfully inflated with encore bsj at 6 atmospheres and held the pressure for 30 seconds.However, upon post-procedure, it took approximately 15 minutes to remove, and deflation was four more times than the usual.The device was removed in a deflated state and the procedure was completed with the original device.There were no patient injuries reported.
Additional Manufacturer Narrative
E1: initial reporter facility: (b)(6) hospital.This report is being filed to correct the model number and unique identifier (udi) # in response to an fda request.
Event or Problem Description
It was reported that balloon deflation slow and difficulty removal occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified internal carotid artery and common carotid artery.A 5.0mmx20mmx135cm (4f) sterling balloon catheter was advanced for dilatation.During procedure, the balloon was successfully inflated with encore bsj at 6 atmospheres and held the pressure for 30 seconds.However, upon post-procedure, it took approximately 15 minutes to remove, and deflation was four more times than the usual.The device was removed in a deflated state and the procedure was completed with the original device.There were no patient 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: 18105667
• Report Number: 2124215-2023-62333
• Device Sequence Number: 6004268
• Product Code: DQY
• UDI-Device Identifier: 08714729756194
• UDI-Public: (01)08714729756194(17)260619(10)31851214
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2024

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 Expiration Date: 06/19/2026
• Device Model Number: H74939031502010
• Device Catalogue Number: 24690
• Device Lot Number: 0031851214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2023
• 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: GUIDING CATHETER USED: OPTIMO 9F TOKAI MEDICAL; GUIDING CATHETER USED: OPTIMO 9F TOKAI MEDICAL; INTRODUCER SHEATH USED: 9F MEDIKIT; INTRODUCER SHEATH USED: 9F MEDIKIT
• Patient Sex: Unknown