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

Model Number	24700
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon deflation failure occurred.The mildly calcified target lesion was 100% occluded and located in the distal superficial femoral artery (sfa) / popliteal artery.Atherectomy and balloon angioplasty with a 5.0mm balloon was performed.A non-boston scientific (bsc) stent was implanted.The stent was double layered over a previously placed non-bsc stent, and the new stent had folded onto itself during its deployment.A 7.0mmx40mmx135cm (4f) sterling balloon catheter was advanced to post dilate the stent.The sterling was passed over the wire and inflated once to approximately 10 atmospheres, in a normal looking portion of the stent; however, the balloon failed to deflate.The physician tried several methods and devices and could not deflate the device.Finally, the physician was able to rupture the balloon using a non-bsc re-entry device.The device was removed intact.The procedure was successfully completed.There were no patient complications.It was further reported the stent remained patent and was asymptomatic one week post procedure.
Event or Problem Description
It was reported that balloon deflation failure occurred.The mildly calcified target lesion was 100% occluded and located in the distal superficial femoral artery (sfa) / popliteal artery.Atherectomy and balloon angioplasty with a 5.0mm balloon was performed.A non-boston scientific (bsc) stent was implanted.The stent was double layered over a previously placed non-bsc stent, and the new stent had folded onto itself during its deployment.A 7.0mmx40mmx135cm (4f) sterling balloon catheter was advanced to post dilate the stent.The sterling was passed over the wire and inflated once to approximately 10 atmospheres, in a normal looking portion of the stent; however, the balloon failed to deflate.The physician tried several methods and devices and could not deflate the device.Finally, the physician was able to rupture the balloon using a non-bsc re-entry device.The device was removed intact.The procedure was successfully completed.There were no patient complications.It was further reported the stent remained patent and was asymptomatic one week post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling balloon catheter stuck inside a merit 6f sheath.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the guidewire lumen is separated 159cm from the tip and the inflation lumen is separated 165.7cm from the tip.The hub and proximal section of the shaft are missing.There are multiple buckling, kinks, and stretched sections along the shaft.Microscopic examination revealed that the tip is damaged.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage to the device that could have contributed to the reported event.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16122513
• Report Number: 2124215-2022-53893
• Device Sequence Number: 15575798
• Product Code: DQY
• UDI-Device Identifier: 08714729124078
• UDI-Public: 08714729124078
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2023

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: 09/22/2025
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0030204976
• 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: 12/14/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown