MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PT; WIRE, GUIDE, CATHETER

Model Number	2777
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	12/02/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.A 185cm light support straight tip pt2 guidewire was inserted into the target lesion that was located in the left anterior descending (lad) artery.However, during the procedure the tip of the wire broke off.The tip was snared from the patient.The procedure was completed with this device.No further patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Visual inspection found the device is broken at the distal section.Only 183 cm were returned.The overall length should be 185 cm.The overall length and outer diameter (od) of the distal tip was unable to measure due to the condition of the device.The od of middle and proximal section of the device was within specifications.
Event or Problem Description
It was reported that tip detachment occurred.A 185cmlight support straight tip pt2 guidewire was inserted into the target lesion that was located in the left anterior descending (lad) artery.However, during the procedure the tip of the wire broke off.The tip was snared from the patient.The procedure was completed with this device.No further patient complications were reported and the patient's status was fine.

• Brand Name: PT
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8162345
• Report Number: 2134265-2018-64009
• Device Sequence Number: 1606470
• Product Code: DQX
• UDI-Device Identifier: 08714729471110
• UDI-Public: 08714729471110
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K030617
• 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): 02/01/2019

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: 10/08/2020
• Device Model Number: 2777
• Device Catalogue Number: 2777
• Device Lot Number: 0022764345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 02/01/2019
• 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