MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STINGRAY LP; CATHETER, PERCUTANEOUS

Model Number	10594
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that marker dots were missing.The 80% stenosed target lesion was located in the mildly tortuous and moderately calcified left anterior descending artery.The device was prepped correctly.During procedure, the device was inserted into the patient's body, however the marker dots could not be seen on angiography.The device was pulled back normally.There were no patient complications reported.
Event or Problem Description
It was reported that marker dots were missing.The 80% stenosed target lesion was located in the mildly tortuous and moderately calcified left anterior descending artery.The device was prepped correctly.During procedure, the device was inserted into the patient's body, however the marker dots could not be seen on angiography.The device was pulled back normally.There were no patient complications reported.It was further reported that a second stingray was pulled and performed as expected.The procedure was completed successfully.The patient was fine post procedure.

• Brand Name: STINGRAY LP
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10600922
• Report Number: 2134265-2020-13402
• Device Sequence Number: 16886321
• Product Code: DQY
• UDI-Device Identifier: 08714729903352
• UDI-Public: 08714729903352
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K152401
• 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): 10/19/2020

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: 06/19/2021
• Device Model Number: 10594
• Device Catalogue Number: 10594
• Device Lot Number: 0023984958
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1