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

Model Number	H74939031403010
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter facility name-(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The patient was placed under local anesthesia and underwent angiography which revealed occlusion in the c1 segment of the right internal carotid artery.An 8f mach1 guide catheter was exchanged and placed at the ostial of internal carotid artery.Along the guide catheter, the guidewire was advanced to the cavernous sinus in the internal carotid artery.A 2.0x15 non-boston scientific (bsc) balloon, a 3x20 balloon, and a 4.0mmx30mmx135cm (4f) sterling balloon were advanced over guidewire for dilation.However, the 4.0mmx30mmx135cm (4f) sterling burst and was replaced with another of same device.The balloon was inflated twice, and the occlusion was obviously improved.After the balloon catheter was removed, an ez filterwire was placed at 2cm distal to the lesion followed by placing a 7x40 wallstent and completing the procedure.There were no complications reported and the patient condition following procedure was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The patient was placed under local anesthesia and underwent angiography which revealed occlusion in the c1 segment of the right internal carotid artery.An 8f mach1 guide catheter was exchanged and placed at the ostial of internal carotid artery.Along the guide catheter, the guidewire was advanced to the cavernous sinus in the internal carotid artery.A 2.0x15 non-boston scientific (bsc) balloon, a 3x20 balloon, and a 4.0mmx30mmx135cm (4f) sterling balloon were advanced over guidewire for dilation.However, the 4.0mmx30mmx135cm (4f) sterling burst and was replaced with another of same device.The balloon was inflated twice, and the occlusion was obviously improved.After the balloon catheter was removed, an ez filterwire was placed at 2cm distal to the lesion followed by placing a 7x40 wallstent and completing the procedure.There were no complications reported and the patient condition following procedure was stable.It was further reported that the 85% stenosed target lesion was located in the moderately tortuous and moderately calcified internal carotid artery.Also, the balloon burst at 8 atmospheres during the initial inflation.
Additional Manufacturer Narrative
E1.Initial reporter facility (b)(6) hospital.
Event or Problem Description
It was reported that balloon rupture occurred.The patient was placed under local anesthesia and underwent angiography which revealed occlusion in the c1 segment of the right internal carotid artery.An 8f mach1 guide catheter was exchanged and placed at the ostial of internal carotid artery.Along the guide catheter, the guidewire was advanced to the cavernous sinus in the internal carotid artery.A 2.0x15 non-boston scientific (bsc) balloon, a 3x20 balloon, and a 4.0mmx30mmx135cm (4f) sterling balloon were advanced over guidewire for dilation.However, the 4.0mmx30mmx135cm (4f) sterling burst and was replaced with another of same device.The balloon was inflated twice, and the occlusion was obviously improved.After the balloon catheter was removed, an ez filterwire was placed at 2cm distal to the lesion followed by placing a 7x40 wallstent and completing the procedure.There were no complications reported and the patient condition following procedure was stable.It was further reported that the 85% stenosed target lesion was located in the moderately tortuous and moderately calcified internal carotid artery.Also, the balloon burst at 8 atmospheres during the initial inflation.
Additional Manufacturer Narrative
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 and microscopic examination revealed no damages.Functional testing was performed by inflating the device to rated burst pressure and it was able to hold pressure.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis could not confirm the reported rupture.E1.Initial reporter facility name-(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The patient was placed under local anesthesia and underwent angiography which revealed occlusion in the c1 segment of the right internal carotid artery.An 8f mach1 guide catheter was exchanged and placed at the ostial of internal carotid artery.Along the guide catheter, the guidewire was advanced to the cavernous sinus in the internal carotid artery.A 2.0x15 non-boston scientific (bsc) balloon, a 3x20 balloon, and a 4.0mmx30mmx135cm (4f) sterling balloon were advanced over guidewire for dilation.However, the 4.0mmx30mmx135cm (4f) sterling burst and was replaced with another of same device.The balloon was inflated twice, and the occlusion was obviously improved.After the balloon catheter was removed, an ez filterwire was placed at 2cm distal to the lesion followed by placing a 7x40 wallstent and completing the procedure.There were no complications reported and the patient condition following procedure was stable.It was further reported that the 85% stenosed target lesion was located in the moderately tortuous and moderately calcified internal carotid artery.Also, the balloon burst at 8 atmospheres during the initial inflation.
Additional Manufacturer Narrative
This report is being filed to correct the model number and unique identifier (udi) # in response to an fda request.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 and microscopic examination revealed no damages.Functional testing was performed by inflating the device to rated burst pressure and it was able to hold pressure.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis could not confirm the reported rupture.E1: initial reporter facility name: (b)(6) hospital.

• 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: 18311093
• Report Number: 2124215-2023-70304
• Device Sequence Number: 6832626
• Product Code: DQY
• UDI-Device Identifier: 08714729756972
• UDI-Public: (01)08714729756972(17)260319(10)31261736
• 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,Followup,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: 03/19/2026
• Device Model Number: H74939031403010
• Device Catalogue Number: 24690
• Device Lot Number: 0031261736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 12/14/2023; 01/30/2024; 06/12/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 12/15/2023; 01/31/2024; 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2023
• 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
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 86 KG