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

Model Number	24690
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a balloon rupture and dissection occurred.The 75% stenosed target lesion was located in the moderately tortuous and severely calcified bilateral common iliac artery.An opticross 18 vascular imaging catheter and a sterling balloon were selected for use.A sheath was inserted from both dorsalis pedis arteries, and a non-boston scientific 0.014-inch guidewire was crossed the lesion.Bilateral lesion dilatation was performed by a small diameter coyote 4-40 balloon before the pre-dilation.The lesion was confirmed by an opticross to be a circumferential severely calcified lesion, so a balloon size with a little extra space for the lumen was selected.The left common iliac artery was dilated using this sterling device.However, upon several inflations at 6 - 10 atmospheres for about 10 seconds, the balloon ruptured vertically.The device was removed using normal method without issue.The dilatation was completed with another of the same device.The right common iliac artery was dilated using sterling 6-40.Afterwards, the lumen was checked using opticross.There was a little resistance.It was possible that the physician pushed a little too hard and it kinked.After several uses, the screen became dark, and it became difficult to confirm the vascularity.The catheter was visible under fluoroscopy.Another opticross was used, and the treatment was continued.Thereafter, epic 10-40 was placed in the lesion on both sides.In addition, post-dilation was performed using the balloon used during pre-dilation.Intravascular ultrasound (ivus) confirmation was performed, and final contrast imaging was performed.The final imaging revealed findings that appeared to be dissection in the common iliac artery.The physician judged that the severe calcification of the lesion may have influenced the dissection.A computed tomography (ct) scan was performed and confirmed no bleeding.The procedure was completed.No complications were reported, and the patient was in good condition post procedure.
Additional Manufacturer Narrative
Device was returned for evaluation.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.No other issues were identified with the device and no patient complications were reported.
Event or Problem Description
It was reported that a balloon rupture and dissection occurred.The 75% stenosed target lesion was located in the moderately tortuous and severely calcified bilateral common iliac artery.An opticross 18 vascular imaging catheter and a sterling balloon were selected for use.A sheath was inserted from both dorsalis pedis arteries and a non-boston scientific 0.014-inch guidewire was crossed the lesion.Bilateral lesion dilatation was performed by a small diameter coyote 4-40 balloon before the pre-dilation.The lesion was confirmed by an opticross to be a circumferential severely calcified lesion, so a balloon size with a little extra space for the lumen was selected.The left common iliac artery was dilated using this sterling device.However, upon several inflations at 6 - 10 atmospheres for about 10 seconds, the balloon ruptured vertically.The device was removed using normal method without issue.The dilatation was completed with another of the same device.The right common iliac artery was dilated using sterling 6-40.Afterwards, the lumen was checked using opticross.There was a little resistance.It was possible that the physician pushed a little too hard and it kinked.After several uses, the screen became dark, and it became difficult to confirm the vascularity.The catheter was visible under fluoroscopy.Another opticross was used, and the treatment was continued.Thereafter, epic 10-40 was placed in the lesion on both sides.In addition, post-dilation was performed using the balloon used during pre-dilation.Intravascular ultrasound (ivus) confirmation was performed, and final contrast imaging was performed.The final imaging revealed findings that appeared to be dissection in the common iliac artery.The physician judged that the severe calcification of the lesion may have influenced the dissection.A computed tomography (ct) scan was performed and confirmed no bleeding.The procedure was completed.No complications were reported, and the patient was in good condition post procedure.

• 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: 20138130
• Report Number: 2124215-2024-51775
• Device Sequence Number: 7416970
• Product Code: DQY
• UDI-Device Identifier: 08714729757443
• UDI-Public: 08714729757443
• 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): 10/01/2024

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: 07/13/2026
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0032016012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2023
• 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: GUIDEWIRE: JUPITER FC 300CM; GUIDEWIRE: JUPITER FC 300CM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male