MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 24703

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2020

Event Type  malfunction  

Event Description

It was reported that shaft perforation occurred.Vascular access was obtained via left femoral artery.The target lesion was located in a vessel in the lower left limb.During preparation of a 2.5mm x 150mm x 150cm sterling sl balloon catheter, it was flushed with saline using a 10ml syringe through the wire line.However, it was noticed that little water comes out of the distal end of the catheter.A v-18 guide wire was passed through the balloon but it did not exit in the distal end of the catheter and it entered near the first ro mark.The guide was removed and it was noted to be deformed.Subsequently, the flushing was again performed but the balloon begins to be inflated even though the solution is being injected through the wire.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.

Event Description

It was reported that shaft perforation occurred.Vascular access was obtained via left femoral artery.The target lesion was located in a vessel in the lower left limb.During preparation of a 2.5mm x 150mm x 150cm sterling sl balloon catheter, it was flushed with saline using a 10ml syringe through the wire line.However, it was noticed that little water comes out of the distal end of the catheter.A v-18 guide wire was passed through the balloon but it did not exit in the distal end of the catheter and it entered near the first ro mark.The guide was removed and it was noted to be deformed.Subsequently, the flushing was again performed but the balloon begins to be inflated even though the solution is being injected through the wire.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.It was further reported that the 75% stenosed target lesion was located in the severely tortuous and mildly calcified artery.After the guidewire exited the shaft, it exited to the balloon without perforating the balloon material and when it was removed, a small perforation/fracture on the shaft near the first ro marker was noted.

Event Description

It was reported that shaft perforation occurred.Vascular access was obtained via left femoral artery.The target lesion was located in a vessel in the lower left limb.During preparation of a 2.5mm x 150mm x 150cm sterling sl balloon catheter, it was flushed with saline using a 10ml syringe through the wire line.However, it was noticed that little water comes out of the distal end of the catheter.A v-18 guide wire was passed through the balloon but it did not exit in the distal end of the catheter and it entered near the first ro mark.The guide was removed and it was noted to be deformed.Subsequently, the flushing was again performed but the balloon begins to be inflated even though the solution is being injected through the wire.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.It was further reported that the 75% stenosed target lesion was located in the severely tortuous and mildly calcified artery.After the guidewire exited the shaft, it exited to the balloon without perforating the balloon material and when it was removed, a small perforation/fracture on the shaft near the first ro marker was noted.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a sterling sl balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen and balloon.The balloon was loosely folded.Microscopic inspection revealed tip damage.There was a pinhole in the inner shaft on the proximal side of the proximal marker band.The hole was consistent with damage from a guidewire.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: STERLING SL
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10115245
• MDR Text Key: 193683895
• Report Number: 2134265-2020-07424
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729782278
• UDI-Public: 08714729782278
• Combination Product (y/n): N
• PMA/PMN Number: K093720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2021
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0024185731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1