MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMPLATZ SUPER STIFF; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number	M0066401040
Medical Device Problem Codes	Break (1069); Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4) captures the reportable investigation results of corewire broken.Visual examination of the returned device revealed that the body was all stretched and the core wire was broken.The complaint was consistent with the reported event of unraveled guidewire.All compiled information on this investigation determines that the most probable cause is unintended use error caused or contributed to event since the evidence shows that there are no deviations regarding the manufacturing process of the device and the evidence of the event shows that the misuse of the device could have caused or contributed to the error.A dhr (device history record) review was performed and no deviation was found.
Event or Problem Description
It was reported to boston scientific corporation that an amplatz guidewire was used during an pcnl (percutaneous nephrolithotomy) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the guidewire unraveled.The procedure was completed with a new amplatz guidewire.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.This event has been deemed a reportable event based on the investigation results: corewire broken.

• Brand Name: AMPLATZ SUPER STIFF
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8475185
• Report Number: 3005099803-2019-01581
• Device Sequence Number: 11169973
• Product Code: EZB
• UDI-Device Identifier: 08714729752660
• UDI-Public: 08714729752660
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 04/02/2019

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: 04/04/2021
• Device Model Number: M0066401040
• Device Catalogue Number: 640-104S
• Device Lot Number: 0021954519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1