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

Model Number	39615
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip detachment and removal difficulties occurred.A 035/260/3mm amplatz super stiff guidewire was inserted into the target lesion.However, the guidewire broke during the procedure.The physician tried to move it but could not.The procedure was completed with a non-boston scientific device.No patient complications were reported.
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device evaluated by mfr.: the complaint device was not returned by the customer; nevertheless, physician has provided pictures of the device.As per pictures provided, it can be the coil wire was unraveled and detached at distal part, also the distal end was bent, also it is possible to see that the information of the label matches with the information of the complaint.The reported complaint distal tip detachment of device or device component and guidewire difficult to remove are confirmed.
Event or Problem Description
It was reported that tip detachment and removal difficulties occurred.A 035/260/3mm amplatz super stiff guidewire was inserted into the target lesion.However, the guidewire broke during the procedure.The physician tried to move it but could not.The procedure was completed with a non-boston scientific device.No patient complications were reported.
Event or Problem Description
It was reported that tip detachment and removal difficulties occurred.A 035/260/3mm amplatz super stiff guidewire was inserted into the target lesion.However, the guidewire broke during the procedure.The physician tried to move it but could not.The procedure was completed with a non-boston scientific device.No patient complications were reported.
Additional Manufacturer Narrative
E1 initial reporter address 1: (b)(6).Device evaluated by mfr.: unit returned in a generic plastic bag, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The physician has provided pictures of the device.As per pictures provided, it can be the coil wire was unraveled and detached at distal part, also the distal end was bent, also it is possible to see that the information of the label matches with the information of the complaint.The guidewire was returned, and the core wire was detached/separated approximately at 3.5cm from distal tip.The rest of the core wire measures approximately 256.9cm.Also, the coil wire was unraveled due de detachment of the core wire.Under microscope it was observed the detachment section of the core wire.The outer diameter of middle of the device, and proximal section are within specifications.The overall length and outer diameter of distal tip could not be measured due the detach/separate condition of the device.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.

• Brand Name: AMPLATZ SUPER STIFF
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15176907
• Report Number: 2124215-2022-28333
• Device Sequence Number: 12030336
• Product Code: DQX
• UDI-Device Identifier: 08714729115861
• UDI-Public: 08714729115861
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K843012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2022

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: 03/29/2025
• Device Model Number: 39615
• Device Catalogue Number: 39615
• Device Lot Number: 0029135201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 08/12/2022; 10/25/2022
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 09/01/2022; 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2022
• 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