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

Model Number 24692

Device Problems Difficult to Remove (1528); Device-Device Incompatibility (2919)

Patient Problem Vascular Dissection (3160)

Event Date 03/11/2019

Event Type  Injury  

Event Description

It was reported that removing difficulties and dissection occurred.Recanalization was performed into the peroneal muscle using a rubicon 0.014 guide catheter wherein a flow has found.A 2.0mm x 100mm x 150cm sterling sl balloon catheter was advanced for dilation in the whole peroneal muscle.However, during withdrawal, it was noted that the balloon remained stuck with the guide catheter at the level of the introducer.When it was about to remove the balloon , the guide was sectioned by leaving a portion in the aorta and in the right atrial appendage (raa) till the peroneal muscle.Dissection of the right femoral tripod, dissection of the common femoral artery were also noted.Subsequently, arteriotomy and removal of the proximal end of the guide was performed.When successful recanalization was obtained, a 6f non-bsc guide catheter and a non-bsc guide wire were placed.Dilatation was then performed with a 3/80 mustang balloon and a non-bsc balloon was advanced to perform further dilatation at the level of the popliteal artery.Finally, two non-bsc stents on the proximal raa and distal raa at the ends with the previous stentings were placed and was post dilated with a non-bsc balloon through all the way the femoral stents.The arteriographic result is correct with a common femoral artery in continuity with the superficial popliteal femoral artery and then the peroneal muscle which is exhausted distally and the procedure was completed.No further patient complications were reported.

Manufacturer Narrative

Updated lot number to 0020933366.Updated expiration date to 07/26/2019.Updated unique identifier (udi)# to (b)(4).Updated device manufacture date to 07/26/2017.Device evaluated by mfr: returned product consisted of a sterling sl otw balloon catheter with an unidentified guide wire.The guide wire was measured with a calibrated snap gage and measured.014".The balloon was loosely folded and there was contrast in the balloon and inflation lumen (shaft).The tip, balloon, markerbands, proximal bond, inner/outer shaft, and port/exit notch were microscopically and visually inspected.Inspection revealed shaft damage (stretched/flattened) for a length of 86 cm with additional shaft damage located 34mm from the port/exit notch, numerous kinks in the shaft, and port damage (stretched/flared/misshapen).The tip of the device and the port/exit notch was measured with a calibrated plug gage, and both ends measured.019".Inspection of the remaining device found no other damage or irregularities.Functional testing of the device was carried out by loading the guide wire into the tip of the sterling device, and the wire advanced without issue and exited out from the port/exit notch.The sterling catheter was also loaded into a (lab supplied) 6f guide catheter, and the device advanced without issue and out from the tip of the guide catheter.

Event Description

It was reported that removing difficulties and dissection occurred.Recanalization was performed into the peroneal muscle using a rubicon 0.014 guide catheter wherein a flow has found.A 2.0mm x 100mm x 150cm sterling sl balloon catheter was advanced for dilation in the whole peroneal muscle.However, during withdrawal, it was noted that the balloon remained stuck with the guide catheter at the level of the introducer.When it was about to remove the balloon , the guide was sectioned by leaving a portion in the aorta and in the right atrial appendage (raa) till the peroneal muscle.Dissection of the right femoral tripod, dissection of the common femoral artery were also noted.Subsequently, arteriotomy and removal of the proximal end of the guide was performed.When successful recanalization was obtained, a 6f non-bsc guide catheter and a non-bsc guide wire were placed.Dilatation was then performed with a 3/80 mustang balloon and a non-bsc balloon was advanced to perform further dilatation at the level of the popliteal artery.Finally, two non-bsc stents on the proximal raa and distal raa at the ends with the previous stentings were placed and was post dilated with a non-bsc balloon through all the way the femoral stents.The arteriographic result is correct with a common femoral artery in continuity with the superficial popliteal femoral artery and then the peroneal muscle which is exhausted distally and the procedure was completed.No further patient complications were reported.

• 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: 8470205
• MDR Text Key: 140507477
• Report Number: 2134265-2019-03275
• Device Sequence Number: 1
• Product Code: LIT
• 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
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2019
• Device Model Number: 24692
• Device Catalogue Number: 24692
• Device Lot Number: 0020933366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Date Manufacturer Received: 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention