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

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Age at time of event: (b)(6).

Event Description

It was reported that the balloon could not cross the lesion an the shaft broke.A 5x40mm sterling balloon and a 2.1 jetstream xc catheter were selected for use during a j-supreme ii study.The target lesion, located in the left distal superficial femoral artery (sfa) extending into the proximal popliteal artery, was 99% stenosed, had a reference vessel diameter of 6.0 mm, length of 130 mm and was classified as a tasc ii b lesion.The target lesion was treated with balloon angioplasty followed by debulking using the jetstream device, resulting in 50% residual stenosis.Post treatment, percutaneous transluminal balloon angioplasty (pta) was performed, with 25% final residual stenosis.During the procedure, ivus was passed through the middle of the popliteal artery, but a calcified nodule protruding into the intravascular lumen was observed.The sterling balloon could not pass through the lesion and the shaft broke making it unusable.The guidewire was changed to a thruway, and then atherectomy was performed a total of three times using the jetstream study device.Subsequent contrast images showed markedly slow flow and distal emboli of left anterior tibial artery, posterior tibial artery and peroneal artery of target limb was noted.Suction was first performed and the debris was successfully suctioned; flow improved.The original lesion was excavated using jetstream, and after pre-dilatation with a non-bsc balloon, drug application was performed using a non-bsc balloon.As it was concerned that the anterior tibial artery flow was poor in the final enhanced imaging, the wire cross was performed again to the anterior tibial artery.There was embolization of debris in the distal part of the anterior tibial artery, and suction catheter and non-bsc balloon could not pass through the same area.Since the non-bsc balloon could not pass through the lesion either, the back-up was enhanced using guidezilla, and then it was successfully passed.Dilatation was performed in the same area.With this dilatation, blood flow improved.The procedure was completed.The sheath was removed and hemostasis was performed using a non-bsc device.The event was considered recovered/resolved.The subject was discharged on aspirin and clopidogrel on (b)(6) 2019.

• Brand Name: STERLING
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; maple grove MN
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8883945
• MDR Text Key: 154000064
• Report Number: 2134265-2019-09529
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1