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

Model Number	40495
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.A 150cm, 8cm poly tip v-18 control wire guidewire was advanced; however, the tip broke off.Subsequently, the physician attempted to retrieve the detached component but the tip was stuck and remained in the patient.The procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the unit returned with the wire bent.The returned device matches with upn provided by the customer.The guidewire returned together with its original opened pouch.The polymer tip was damaged; a section of the polymer was detached, approximately 4 cm was separated from the tip and this section was not returned.The distal tip was bent.No more damages were found in the returned device.Overall length was found within specification.The od of the distal tip could not be measured due to the tip detachment.The od of the middle and proximal section of the device were found within specification.
Event or Problem Description
It was reported that tip detachment occurred.A 150cm, 8cm poly tip v-18 control wire guidewire was advanced; however, the tip broke off.Subsequently, the physician attempted to retrieve the detached component but the tip was stuck and remained in the patient.The procedure was completed with a different device.There were no patient complications reported.

• Brand Name: V-18 CONTROL WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9841699
• Report Number: 2134265-2020-03317
• Device Sequence Number: 16857887
• Product Code: DQX
• UDI-Device Identifier: 08714729070184
• UDI-Public: 08714729070184
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K033742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2020

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: 12/10/2021
• Device Model Number: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0024912355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR