MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION V-14 CONTROL WIRE; WIRE, GUIDE, CATHETER

Model Number	40458
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that tip separation occurred.A 300cm straight tip v-14 control wire was advanced to cross the lesion.However, after the wire was withdrawn from the patient's body, the tip of the device was found separated and was visually describe to be branch like.Separation was observed but the tip was not fully detached.The procedure was completed.The physician put the patient under observation; however, no patient complications were reported.
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.Device was evaluated by mfr.: the device was returned for analysis.Unit returned with its original box.The unit returned has the wire tip damaged, as part of overall visual revision.The distal tip of the guidewire had the polymer detached; the damaged section was located approximately at 299 cm from the proximal end.The detached section was not returned.The distal tip was kinked approximately at 298 cm from the proximal end.No more damages were found in the device.Some pictures with more details were captured to the damaged area found in the distal section of the guidewire.The outer diameter of the middle of the device and proximal section were within specifications.However, the overall length and outer diameter of the distal tip could not be performed due to device condition (polymer tip detached).
Event or Problem Description
It was reported that tip separation occurred.A 300cm straight tip v-14 control wire was advanced to cross the lesion.However, after the wire was withdrawn from the patient's body, the tip of the device was found separated and was visually describe to be branch like.Separation was observed but the tip was not fully detached.The procedure was completed.The physician put the patient under observation; however, no patient complications were reported.

• Brand Name: V-14 CONTROL WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9627919
• Report Number: 2134265-2020-00427
• Device Sequence Number: 2884632
• Product Code: DQX
• UDI-Device Identifier: 08714729799269
• UDI-Public: 08714729799269
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K112745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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: 05/22/2021
• Device Model Number: 40458
• Device Catalogue Number: 40458
• Device Lot Number: 0023843884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 01/24/2020
• Supplement Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1