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

Model Number	24700
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon and wire became stuck during the procedure.A 5.0 mm x 20 mm x 135 cm (4f) sterling balloon and a v-18 control wire were selected for a difficult and complex procedure to treat a ruptured fewar prosthesis, a fenestrated prosthesis with many outlets including the kidney.There was no stenosis or calcification at this site.The patient was seriously ill at the time of the procedure.The physician intended to rebuild the renal artery on the left, since the non-bsc stent, which had been previously implanted, was completely torn.The physician wanted to place a new stent over the old stent.The doctor tried to probe the vessel with the v18 wire and finally managed to get it through the meshes of the underlying stent with the sterling balloon by dilating the area to make a small lumen.After this, the physician attempted to remove the balloon from the v18 wire, so that a stent could be passed over the v18 wire, but the balloon and the wire could not be separated.No kinks were noted on the wire that could have contributed to this issue.The physician pulled both devices out of the patient together loosing access to the target site.There was an inability to regain access and pass through the old torn stent.As a result, the renal artery had to be coiled, as it bled more and more.It was not known if a new stent would have saved the kidney.The patient is currently being treated with dialysis.No further complications were reported.
Event or Problem Description
It was reported that the balloon and wire became stuck during the procedure.A 5.0mmx20mmx135cm (4f) sterling balloon and a v-18 control wire were selected for a difficult and complex procedure to treat a ruptured fewar prosthesis, a fenestrated prosthesis with many outlets including the kidney.There was no stenosis or calcification at this site.The patient was seriously ill at the time of the procedure.The physician intended to rebuild the renal artery on the left, since the non-bsc stent, which had been previously implanted, was completely torn.The physician wanted to place a new stent over the old stent.The doctor tried to probe the vessel with the v18 wire and finally managed to get it through the meshes of the underlying stent with the sterling balloon by dilating the area to make a small lumen.After this, the physician attempted to remove the balloon from the v18 wire, so that a stent could be passed over the v18 wire, but the balloon and the wire could not be separated.No kinks were noted on the wire that could have contributed to this issue.The physician pulled both devices out of the patient together loosing access to the target site.There was an inability to regain access and pass through the old torn stent.As a result, the renal artery had to be coiled, as it bled more and more.It was not known if a new stent would have saved the kidney.The patient is currently being treated with dialysis.No further complications were reported.It was further reported that the procedure was indicated to treat a mildy tortuous ruptured aortic aneurysm in a patient with history of fever and an "endoleak" via a fractured and dissolved bridging stent to the renal artery.The renal artery and renal branch had to be coiled to exclude the endoleak.The patient's renal function was already close to dialysis prior to the start of the procedure.The renal artery was not bleeding.The initial wiring of the broken covered stent with dissolved coating was very difficult.There was no difficulty removing the wire and balloon from the patient when they became stuck together.Had it been possible to insert a new renal bridging-stent via the v18 control wire, instead of coiling the artery, the patient's outcome concerning renal function might have been better.However, no further complications or interventions were needed.The patient survived and was scheduled for a follow-up ct scan.
Event or Problem Description
It was reported that the balloon and wire became stuck during the procedure.A 5.0mmx20mmx135cm (4f) sterling balloon and a v-18 control wire were selected for a difficult and complex procedure to treat a ruptured fewar prosthesis, a fenestrated prosthesis with many outlets including the kidney.There was no stenosis or calcification at this site.The patient was seriously ill at the time of the procedure.The physician intended to rebuild the renal artery on the left, since the non-bsc stent, which had been previously implanted, was completely torn.The physician wanted to place a new stent over the old stent.The doctor tried to probe the vessel with the v18 wire and finally managed to get it through the meshes of the underlying stent with the sterling balloon by dilating the area to make a small lumen.After this, the physician attempted to remove the balloon from the v18 wire, so that a stent could be passed over the v18 wire, but the balloon and the wire could not be separated.No kinks were noted on the wire that could have contributed to this issue.The physician pulled both devices out of the patient together loosing access to the target site.There was an inability to regain access and pass through the old torn stent.As a result, the renal artery had to be coiled, as it bled more and more.It was not known if a new stent would have saved the kidney.The patient is currently being treated with dialysis.No further complications were reported.It was further reported that the procedure was indicated to treat a mildy tortuous ruptured aortic aneurysm in a patient with history of fever and an "endoleak" via a fractured and dissolved bridging stent to the renal artery.The renal artery and renal branch had to be coiled to exclude the endoleak.The patient's renal function was already close to dialysis prior to the start of the procedure.The renal artery was not bleeding.The initial wiring of the broken covered stent with dissolved coating was very difficult.There was no difficulty removing the wire and balloon from the patient when they became stuck together.Had it been possible to insert a new renal bridging-stent via the v18 control wire, instead of coiling the artery, the patient's outcome concerning renal function might have been better.However, no further complications or interventions were needed.The patient survived and was scheduled for a follow-up ct scan.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a sterling balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.The shaft under the strain relief was buckled for 25mm.Microscopic inspection revealed tip damage.The device was functionally tested with a.018'' guidewire.The guidewire was unable to pass the buckled damage.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8870934
• Report Number: 2134265-2019-09183
• Device Sequence Number: 618079
• Product Code: DQY
• UDI-Device Identifier: 08714729122838
• UDI-Public: 08714729122838
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K053116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2019

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: 07/01/2021
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0022325158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 08/13/2019; 09/15/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 08/22/2019; 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR