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

Model Number	24700
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Foreign Body In Patient (2687)
Date of Event	06/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred requiring surgical intervention.The 70% stenosed target lesion was located in superficial femoral artery.During angioplasty, a 2.0x60x150 sterling balloon catheter was advanced and inflated at 6 atmospheres for 30 seconds.However, during removal, the balloon shaft broke off and was left in the patient.It was further observed during palpation on a manual pressure hold, that the accessed site was hard and unusual.Finally, the physician cut the access site open and removed the sheared balloon with a pair of hemostats.The device was removed fully deflated and there were no patient complications nor injuries reported.
Additional Manufacturer Narrative
H6 - patient codes: corrected.
Event or Problem Description
It was reported that shaft break occurred requiring surgical intervention.The 70% stenosed target lesion was located in superficial femoral artery.During angioplasty, a 2.0x60x150 sterling balloon catheter was advanced and inflated at 6 atmospheres for 30 seconds.However, during removal, the balloon shaft broke off and was left in the patient.It was further observed during palpation on a manual pressure hold, that the accessed site was hard and unusual.Finally, the physician cut the access site open and removed the sheared balloon with a pair of hemostats.The device was removed fully deflated and 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: 17426785
• Report Number: 2124215-2023-39131
• Device Sequence Number: 5922194
• Product Code: LIT
• UDI-Device Identifier: 08714729859956
• UDI-Public: 08714729859956
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K141112
• 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,Followup
• Report Date (Section B): 08/16/2023

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: 04/24/2026
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0031491034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown