MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STINGRAY; WIRE, GUIDE, CATHETER

Model Number 10598

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2018

Event Type  malfunction  

Event Description

It was reported that the wire froze inside the stingray balloon.The chronic totally occluded target lesion was located in right coronary artery.A 185cm stingray guidewire and a stingray lp catheter were selected for use.During the procedure, the stingray balloon was distally down with the wire to do re-entry; however, the wire froze inside the stingray balloon.The devices were then taken out from the vessel and the vessel was successfully opened with the use of stents.The procedure was completed with a different device no patient complications were reported.

Manufacturer Narrative

This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/19/2018 02:44 pm ct.The report number is being corrected from: 2134265-2018-64523 to: 2134265-2018-64340.

Event Description

It was reported that the wire froze inside the stingray balloon.The chronic totally occluded target lesion was located in right coronary artery.A 185cm stingray guidewire and a stingray lp catheter were selected for use.During the procedure, the stingray balloon was distally down with the wire to do re-entry; however, the wire froze inside the stingray balloon.The devices were then taken out from the vessel and the vessel was successfully opened with the use of stents.The procedure was completed with a different device no patient complications were reported.It was further reported that the devices were removed safely form the patient's body.The procedure was successful with different technology.No physical damage were observed on the device.

• Brand Name: STINGRAY
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8169222
• MDR Text Key: 130494590
• Report Number: 2134265-2018-64340
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08714729837541
• UDI-Public: 08714729837541
• Combination Product (y/n): N
• PMA/PMN Number: K122795
• 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: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 10598
• Device Catalogue Number: 10598
• Device Lot Number: 0022608726
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/17/2018
• Supplement Dates Manufacturer Received: 12/05/2018
• Supplement Dates FDA Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 85 YR