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	06/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a stingray guidewire became stuck in the stingray lp.The target lesion was located in the totally occluded right coronary artery.A stingray guidewire and stingray lp catheter were selected for use.During procedure, it was noted that the guidewire would no longer exit the catheter and became caught and lodged in the exit port after multiple attempts to exit the balloon and enter the true line after a planned dissection.Both devices were removed together from the patient's body through the guide catheter.The procedure was not completed due to the event.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The shaft and tip were microscopically and visually examined.Visual and microscopic examination revealed that the distal end of the coil was stretched out past the corewire and broke off.The portion of the distal coil was detached along with the tip of the device, 18cm distal of the solder weld.The separated end of the coil showed damage from resistance.The detached coil/tip were found inside of the stingray lp catheter for the related complaint that was used in the procedure with this device.The proximal end of the detached coil inside the catheter was stretched and the coil/tip in balloon appeared to be bunched-up.The guidewire was attempted to be removed but was unsuccessful.Inspection of the device presented no other damage or irregularities to the device.
Event or Problem Description
It was reported that a stingray guidewire became stuck in the stingray lp.The target lesion was located in the totally occluded right coronary artery.A stingray guidewire and stingray lp catheter were selected for use.During procedure, it was noted that the guidewire would no longer exit the catheter and became caught and lodged in the exit port after multiple attempts to exit the balloon and enter the true line after a planned dissection.Both devices were removed together from the patient's body through the guide catheter.The procedure was not completed due to the event.No patient complications were reported.

• 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: 8764509
• Report Number: 2134265-2019-07840
• Device Sequence Number: 14094668
• Product Code: DQX
• UDI-Device Identifier: 08714729837527
• UDI-Public: 08714729837527
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/06/2019

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: 04/01/2020
• Device Model Number: 10598
• Device Catalogue Number: 10598
• Device Lot Number: 0022543502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Initial Date Received by Manufacturer: 06/14/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 07/05/2019
• Supplement Report FDA Received Date: 08/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1