MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMPLATZ SUPER STIFF; WIRE, GUIDE, CATHETER

Model Number	39615
Medical Device Problem Codes	Unraveled Material (1664); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	08/31/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guide wire tip detachment and thrombosis occurred.The target lesion was located in the common femoral artery (cfa).A 035/180/3mm (b/1) amplatz guide wire was advanced to cross the lesion.However, it was noted that the j tip was detached from the core of the wire and the wire unraveled, and caused flow limiting clot in the cfa.The tip had to snare out and do a thrombectomy with a tpa bolus and balloon angioplasty.The procedure was completed with a different device.No further patient complications were reported.The intended percutaneous transluminal angioplasty of the other leg was discontinued.
Event or Problem Description
It was reported that guide wire tip detachment and thrombosis occurred.The target lesion was located in the common femoral artery (cfa).A 035/180/3mm (b/1) amplatz guide wire was advanced to cross the lesion.However, it was noted that the j tip was detached from the core of the wire and the wire unraveled, and caused flow limiting clot in the cfa.The tip had to snare out and do a thrombectomy with a tpa bolus and balloon angioplasty.The procedure was completed with a different device.No further patient complications were reported.The intended percutaneous transluminal angioplasty of the other leg was discontinued.
Additional Manufacturer Narrative
Device evaluated by mfr.: unit returned with its original pouch.The unit returned has the tip damaged and is stuck inside of a non-bsc catheter, as part of overall visual revision.The returned guidewire was found unraveled, the coiled wire was found stretched along the distal end; in addition, the core wire is broken.The outer dimater of the medium and proximal section of the device were within specificaion; however the overall length and the outer diameter section of the device could not be perfomed due to device condition (guide wire unravel.Coiled wire stretched and core wire broken).

• Brand Name: AMPLATZ SUPER STIFF
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10553288
• Report Number: 2134265-2020-12418
• Device Sequence Number: 3146190
• Product Code: DQX
• UDI-Device Identifier: 08714729295648
• UDI-Public: 08714729295648
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K843012
• 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): 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2023
• Device Model Number: 39615
• Device Catalogue Number: 39615
• Device Lot Number: 0025292627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention