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

Model Number	39575
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that distal tip of guidewire detachment occurred.A 0.035in x 180cm amplatz super stiff guidewire selected for use for a percutaneous nephrolithotomy (pcnl) procedure.Due to patient's kidney being full of stones, the amplatz guidewire had difficulty to advancing through the kidney to the bladder.After multiple attempts, the guidewire was removed from the patient.The radiologist noticed the distal tip of the guidewire was damaged and a portion of the distal tip was missing.The detachment of the distal tip confirmed by measuring the amplatz guidewire.Several bags of saline for irrigation were used to helped flush out the detachment portion of the amplatz guidewire.At the end of the procedure, the physician x-rayed the patient to confirm nothing was left behind.It was concluded that missing portion of the amplatz guidewire was flushed out.The procedure completed by using nephroscope and ultrasound to break the kidney stones.No patient complications reported and the patient's status was stable post procedure.
Event or Problem Description
It was reported that distal tip of guidewire detachment occurred.A 0.035in x 180cm amplatz super stiff guidewire selected for use for a percutaneous nephrolithotomy (pcnl) procedure.Due to patient's kidney being full of stones, the amplatz guidewire had difficulty to advancing through the kidney to the bladder.After multiple attempts, the guidewire was removed from the patient.The radiologist noticed the distal tip of the guidewire was damaged and a portion of the distal tip was missing.The detachment of the distal tip confirmed by measuring the amplatz guidewire.Several bags of saline for irrigation were used to helped flush out the detachment portion of the amplatz guidewire.At the end of the procedure, the physician x-rayed the patient to confirm nothing was left behind.It was concluded that missing portion of the amplatz guidewire was flushed out.The procedure completed by using nephroscope and ultrasound to break the kidney stones.No patient complications reported and the patient's status was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the returned product consisted of a 0.035in x 180cm amplatz super stiff guidewire.The returned guidewire was inside of a hoop and it was removed without problem for visual inspection.Visual examination revealed that the coil wires were correctly attached to the solder ball, the guidewire was complete and it did not have detached sections.However, the core wire protruded at the distal tip, besides, it was bent in different sections of the tip.The guidewire coating was inspected and no damages were observed.Dimensional measurement found that the overall dimension of middle of the device and proximal section were each 0.0347 inches within specification.An overall length and overall dimension of distal tip could not be performed due to the core wire protruded at the distal end.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• 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: 9274445
• Report Number: 2134265-2019-13178
• Device Sequence Number: 1573055
• Product Code: DQX
• UDI-Device Identifier: 08714729295730
• UDI-Public: 08714729295730
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K843013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2019

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: 0023791864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Initial Date Received by Manufacturer: 10/12/2019
• Supplement Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1