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

Model Number	39575
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire tip detachment and removal difficulties occurred which resulted in additional intervention.The patient presented with herniated disc.The target lesion was located in the non- tortuous and non-calcified lumbar spine.A 035/145 amplatz super stiff wire was selected for use.The physician used a metal needle during insertion.A resistance was felt during insertion of the device, afterwards, the device stopped coming out and switched from the needle cannula to the dilator.However, resistance in removing the device was encountered and about 5 cm from the tip was detached.As a result, the tip of the wire remained in the body, and it took a long time to incise the intervertebral disc drainage site from the body surface using an electrocautery scalpel to open the remaining part.Hence, the detached tip was removed from the intervertebral disc located between the lumbar vertebrae.The operation was then switched to removing it, resulting in a long procedure, so the procedure was not completed.For the purpose of draining the fluid between the lumbar vertebral body.An 18g cannula needle was used to identify the area between the vertebral body and punctured, then the device was inserted into the vertebral body tissue, and the cannula was removed with making a slight loop at the tip of the wire.After that, the body surface was expanded with a plastic dilator, and then a drainage catheter was placed along the wire to complete the procedure.No patient complications nor injuries were reported.
Event or Problem Description
It was reported that guidewire tip detachment and removal difficulties occurred which resulted in additional intervention.The patient presented with herniated disc.The target lesion was located in the non- tortuous and non-calcified lumbar spine.A 035/145 amplatz super stiff wire was selected for use.The physician used a metal needle during insertion.A resistance was felt during insertion of the device, afterwards, the device stopped coming out and switched from the needle cannula to the dilator.However, resistance in removing the device was encountered and about 5 cm from the tip was detached.As a result, the tip of the wire remained in the body, and it took a long time to incise the intervertebral disc drainage site from the body surface using an electrocautery scalpel to open the remaining part.Hence, the detached tip was removed from the intervertebral disc located between the lumbar vertebrae.The operation was then switched to removing it, resulting in a long procedure, so the procedure was not completed.For the purpose of draining the fluid between the lumbar vertebral body.An 18g cannula needle was used to identify the area between the vertebral body and punctured, then the device was inserted into the vertebral body tissue, and the cannula was removed with making a slight loop at the tip of the wire.After that, the body surface was expanded with a plastic dilator, and then a drainage catheter was placed along the wire to complete the procedure.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
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 costumer provides four photos of the device and, it is possible to see that the coil wire was unraveled and detached due the core wire was detached.The guidewire was returned with a non-bsc device, and it was observed that the coil wire was unraveled and detached due the core wire was found detached separated approximately 2.5cm from distal tip to the transition point.Additionally, the core wire was kinked at the distal section.No more damages were observed.Under microscope it was observed that the core wire was detached separated at the transition point and the coil wire was unraveled and detached.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; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16763872
• Report Number: 2124215-2023-15239
• Device Sequence Number: 3063698
• Product Code: DQX
• UDI-Device Identifier: 08714729115946
• UDI-Public: 08714729115946
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/20/2024
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0028910221
• 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: 03/25/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown