MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAGIC TORQUE DLVR; WIRE, GUIDE, CATHETER

Model Number	1013-02
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire and catheter entrapment occurred.The target lesion was located in the superficial femoral artery.A.035 magic torque guidewire was used with a 7x100, 130cm eluvia self-expanding stent.During the procedure the guidewire became stuck within the stent delivery system and could not be removed.The magic torque guidewire and the eluvia stent delivery system were removed together as one unit.The procedure was then completed using a new guidewire and a 7x40mm eluvia stent.No patient complications were reported.
Event or Problem Description
It was reported that guidewire and catheter entrapment occurred.The target lesion was located in the superficial femoral artery.A.035 magic torque guidewire was used with a 7x100, 130cm eluvia self-expanding stent.During the procedure the guidewire became stuck within the stent delivery system and could not be removed.The magic torque guidewire and the eluvia stent delivery system were removed together as one unit.The procedure was then completed using a new guidewire and a 7x40mm eluvia stent.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer.The device was received for analysis.It was observed that the blue sleeve had several kinks along the device.Additionally, the spring tip was bent.The outer diameter dimensions were found within specification.

• Brand Name: MAGIC TORQUE DLVR
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9136354
• Report Number: 2134265-2019-11794
• Device Sequence Number: 19288889
• Product Code: DQX
• UDI-Device Identifier: 08714729982906
• UDI-Public: 08714729982906
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K933334
• 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): 12/05/2019

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: 10/23/2021
• Device Model Number: 1013-02
• Device Catalogue Number: 1013-02
• Device Lot Number: 0022841020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 11/29/2019
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STENT: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM