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

Model Number	39695
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that core wire break occurred.The target lesion was located in the kidney.A 75cm.035 amplatz guidewire was advanced to cross the lesion.Removal difficulty was noted when removing the wire from the nephrostomy catheter.The wire was then noted to be stretched, unwind and core wire was broken.No patient complications nor injuries were reported.
Event or Problem Description
It was reported that core wire break occurred.The target lesion was located in the kidney.A 75cm.035 amplatz guidewire was advanced to cross the lesion.Removal difficulty was noted when removing the wire from the nephrostomy catheter.The wire was then noted to be stretched, unwinded and core wire was broken.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: unit returned in a generic plastic bag.The unit returned has the tip damaged, as part of overall visual revision.The device returned unraveled with the core wire broken near the distal tip; it is important to mention that the distal section of the core wire was attached to the welded tip.Besides, the coil was kinked and stretched.Despite the core wire is broken, it seemed to be that the it was complete.The device was inspected.Middle of the device and proximal section were within specification.

• 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: 8246888
• Report Number: 2134265-2018-65083
• Device Sequence Number: 1594318
• Product Code: DQX
• UDI-Device Identifier: 08714729114604
• UDI-Public: 08714729114604
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K843018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2019

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: 09/11/2021
• Device Model Number: 39695
• Device Catalogue Number: 39695
• Device Lot Number: 0022645009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 02/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1