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	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guide wire tip detachment occurred.The target lesion was located in a iliac/femoralis artery.A 150cm, 8cm poly tip v-18 control wire was selected for use.However, during withdrawal, the tip of the guidewire broke and fell off inside the catheter.The device was removed safely.No patient serious injury or adverse event were reported.
Event or Problem Description
It was reported that guide wire tip detachment occurred.The target lesion was located in a iliac/femoralis artery.A 150cm, 8cm poly tip v-18 control wire was selected for use.However, during withdrawal, the tip of the guidewire broke and fell off inside the catheter.The device was removed safely.No patient serious injury or adverse event were reported.
Additional Manufacturer Narrative
Updated from: initial reporter info (b)(6) to (b)(6).
Event or Problem Description
It was reported that guide wire tip detachment occurred.The target lesion was located in a iliac/femoralis artery.A 150cm, 8cm poly tip v-18 control wire was selected for use.However, during withrawal, the tip of the guidewire broke and fell off inside the catheter.The device was removed safely.No patient serious injury or adverse event were reported.
Additional Manufacturer Narrative
Updated from: initial reporter facility name: (b)(6).Initial reporter address 1: (b)(6).Initial reporter city: (b)(6).To: initial reporter facility name: (b)(6).Initial reporter address 1: (b)(6).Initial reporter city: (b)(6).Device evaluated by mfr.: the device was returned for analysis.Analysis revealed the device was broken on 148 cm from distal section to broken section, overall length should be 150 cm.The overall length and the outer diameter (od) of the distal tip of the device were unable to be measured due to device condition.The od of the middle and proximal section of the device were measured to be within specification.Inspection of the remainder of the device presented no other damages or irregularities.

• 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: 8536846
• Report Number: 2134265-2019-04198
• Device Sequence Number: 361567
• Product Code: DQX
• UDI-Device Identifier: 08714729070184
• UDI-Public: 08714729070184
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K033742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/13/2019

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: 12/15/2019
• Device Model Number: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0021521500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 04/23/2019; 06/07/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 05/09/2019; 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1