MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION V-18 CONTROL WIRE; WIRE, GUIDE, CATHETER

Model Number	40495
Medical Device Problem Codes	Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire was stuck in the catheter.A 2x40x90 sterling balloon catheter was advanced for dilation along with a 200cm, 8cm v18 control guidewire.During the procedure, the balloon was inflated and deflated successfully.Upon removal of the balloon, it was not able to be removed from the wire.The physician tried to pull it back gently over the wire, but it did not resolve the issue.Subsequently, both the balloon and the guidewire were taken out together from the patient, and successfully managed to remove the wire from the balloon shaft.The procedure was completed with another v-18 wire.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The device was returned for the analysis, and it is possible to see that the guidewire was bent distal tip and middle section.Also, the original pouch was returned, and it was observed that the pouch information matches with the complaint information.Based on the evidence, the as reported code body entrapment of device or device component can be confirmed due the device condition.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.
Event or Problem Description
It was reported that the guidewire was stuck in the catheter.A 2x40x90 sterling balloon catheter was advanced for dilation along with a 200cm, 8cm v18 control guidewire.During the procedure, the balloon was inflated and deflated successfully.Upon removal of the balloon, it was not able to be removed from the wire.The physician tried to pull it back gently over the wire, but it did not resolve the issue.Subsequently, both the balloon and the guidewire were taken out together from the patient, and successfully managed to remove the wire from the balloon shaft.The procedure was completed with another v-18 wire.There were no patient complications reported.

• Brand Name: V-18 CONTROL WIRE
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19391294
• Report Number: 2124215-2024-30085
• Device Sequence Number: 7049377
• Product Code: DQX
• UDI-Device Identifier: 08714729070191
• UDI-Public: 08714729070191
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K033742
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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: 10/26/2025
• Device Model Number: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0032738670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON: STERLING; BALLOON: STERLING
• Patient Sex: Unknown