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

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2020

Event Type  malfunction  

Event Description

(b)(6) clinical study.It was reported that the balloon over extended during inflation.In (b)(6) 2020, the index procedure was performed.The target lesion was in the right peroneal artery with 99% stenosis, proximal and distal reference vessel diameter was 3.25 mm and 3.0 mm respectively with a length of 60 mm.As a treatment, orbital atherectomy was performed.Post atherectomy, balloon angioplasty was attempted with sterling balloon but there was significant 'watermelon seeding' of the irregular balloon.The balloon was withdrawn and the lesion was treated with a 4.0 mm x 15 mm cutting balloon to pre-dilate the lesion at burst pressures with a 20% residual stenosis.Post pre-dilation, the lesion was further treated with placing a 3.5 mm x 80 mm study stent.Post dilation was performed with residual stenosis of 0%.

Event Description

Saval pivotal clinical study.It was reported that the balloon over extended during inflation.In (b)(6) 2020, the index procedure was performed.The target lesion was in the right peroneal artery with 99% stenosis, proximal and distal reference vessel diameter was 3.25 mm and 3.0 mm respectively with a length of 60 mm.As a treatment, orbital atherectomy was performed.Post atherectomy, balloon angioplasty was attempted with sterling balloon but there was significant 'watermelon seeding' of the irregular balloon.The balloon was withdrawn and the lesion was treated with a 4.0 mm x 15 mm cutting balloon to pre-dilate the lesion at burst pressures with a 20% residual stenosis.Post pre-dilation, the lesion was further treated with placing a 3.5 mm x 80 mm study stent.Post dilation was performed with residual stenosis of 0% it was further reported that prior treating the target lesion, the superficial femoral artery (non-target lesion) with 95% stenosis was treated with sterling balloon catheter.The orbital atherectomy was performed at low speed.A significant wire bias precluded failure speed.

• Brand Name: STERLING
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10351162
• MDR Text Key: 201526696
• Report Number: 2134265-2020-10189
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR