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

Model Number	10598
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2018
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8169222
• Report Number: 2134265-2018-64340
• Device Sequence Number: 19183931
• Product Code: DQX
• UDI-Device Identifier: 08714729837541
• UDI-Public: 08714729837541
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR