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

Model Number	M0066401091
Medical Device Problem Codes	Unraveled Material (1664); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a amplatz super stiff as being used in a procedure performed on (b)(6) 2021.During insertion, the plastic covering on the wire came off in use, and uncoiled.This was noticed upon removal.The procedure was cancelled due to this event.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
The health care facility name is (b)(6).The physician's name is unknown.(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
H6 (impact codes): impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.H6 (evaluation conclusion codes): the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a amplatz super stiff as being used in a procedure performed on july 17, 2021.During insertion, the plastic covering on the wire came off in use, and uncoiled.This was not noticed until the wire was removed.The procedure was cancelled due to this event.There were no patient complications reported as a result of this event.Additional information received on may 6, 2022: the procedure was completed with a new amplatz super stiff.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14283236
• Report Number: 3005099803-2022-02493
• Device Sequence Number: 6714730
• Product Code: EZB
• UDI-Device Identifier: 08714729191193
• UDI-Public: 08714729191193
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2022

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: 03/01/2024
• Device Model Number: M0066401091
• Device Catalogue Number: 640-109
• Device Lot Number: 0026901263
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown