MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRA ICE PLUS - PI CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 1816-06

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2019

Event Type  Injury  

Event Description

It was reported that advancement difficulties were encountered resulting in stent migration requiring additional intervention. A 16 x 90 x 100 vici self expanding stent was selected for a left common iliac stenting procedure. The non-thrombotic section to be treated was 20-30 mm. During the procedure, the stent was implanted with no complications. The leading edge of the stent was placed in the proximal lciv and extended to proximal leiv. The physician then attempted to advance multiple catheters into the stent and was met with resistance at the proximal ostium of the stent. When the physician was attempting to advance the ultra ice catheter into the stent to visualize it, the vessel was so tortuous that the catheter pushed against the end of the stent and it dislodged from where it was originally implanted. The leading edge of the stent was now in the distal ivc extending into the lciv. A balloon was used to pull the stent down and an apposing stent was placed from the distal ivc into the right civ and the stent on the left was extended into the leiv. No further patient complications were reported.

• Brand Name: ULTRA ICE PLUS - PI
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9105396
• MDR Text Key: 161055532
• Report Number: 2134265-2019-11532
• Device Sequence Number: 1
• Product Code: DXK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1816-06
• Device Catalogue Number: 1816-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/29/2019
• 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 Treatment Data

Date Received: 09/23/2019 Patient Sequence Number: 1