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

Model Number	39815
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the innova delivery system was stuck on the wire.A magic torque guidewire and a 7x150x130 innova vascular stent were selected for a stent procedure in the superficial femoral artery (sfa).During the procedure, there was difficulty advancing the innova device.The innova stent was deployed safely into the patient.The delivery system was difficult to remove and became stuck on the magic torque guidewire.Everything was removed together.The physician lost wire position.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned in its original pouch.Analysis of returned product revealed that the guidewire has kinks at several sections.The outer diameter dimensions were found within specification.The kinks would contribute to the reported issues.
Event or Problem Description
It was reported that the innova delivery system was stuck on the wire.A magic torque guidewire and a 7x150x130 innova vascular stent were selected for a stent procedure in the superficial femoral artery (sfa).During the procedure, there was difficulty advancing the innova device.The innova stent was deployed safely into the patient.The delivery system was difficult to remove and became stuck on the magic torque guidewire.Everything was removed together.The physician lost wire position.There were no patient complications.

• Brand Name: MAGIC TORQUE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8441644
• Report Number: 2134265-2019-02701
• Device Sequence Number: 11411553
• Product Code: DQX
• UDI-Device Identifier: 08714729114628
• UDI-Public: 08714729114628
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 04/12/2019

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: 12/10/2021
• Device Model Number: 39815
• Device Catalogue Number: 39815
• Device Lot Number: 0023066660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 03/21/2019
• Supplement Report FDA Received Date: 04/12/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7X150X130 INNOVA STENT; 7X150X130 INNOVA STENT