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

Model Number	39575
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the unit returned has the wire tip damaged, as part of overall visual revision.The device returned together with its original opened pouch and inside of a plastic hoop.The guidewire was unraveled and the coil wire was elongated.The core wire was broken approximately at 139.5 cm from the proximal end.Attached to the distal tip solder ball there was another core wire section and it measured approximately 5 cm.No more damages were found in the returned device.Overall length and outer diameter (od) of distal tip could not be performed due to device condition of guidewire unraveled.Od of middle of the device and proximal section are within specification.
Event or Problem Description
Reportable based on device analysis completed on 29-nov-2019.It was reported that the guidewire unraveled.A 035/145 amplatz super stiff guidewire was advanced to cross the lesion.However, during the procedure, it was noted that the guidewire unraveled.The procedure was completed with another of the same device.There were no patient complications reported.However, returned device analysis revealed the core wire was 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: 9470450
• Report Number: 2134265-2019-15453
• Device Sequence Number: 13993164
• Product Code: DQX
• UDI-Device Identifier: 08714729295716
• UDI-Public: 08714729295716
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K843015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2019

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 Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0024279861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2019
• Initial Report FDA Received Date: 12/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 44