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

Model Number	2779
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/02/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a guidewire break occurred.A 185cm pt2 guidewire was selected for use in a cardiac procedure.However, the wire broke inside the patient's body.No attempt was made to remove the broken portion.It was noted that the broken guidewire did not travel or move through the artery after the brake occurred.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
The device was returned for analysis.The guidewire returned inside of a hoop together with its original opened pouch.The guidewire was removed from the hoop without problems.Once the wire was inspected, it was found a section of the polymer tip was detached approximately at 183.3 cm from the proximal end.The detached section was not returned.The distal tip was found bent.A kinked section was found in the proximal end of the guidewire, located approximately at 0.8 cm from the proximal end.No more damages were found.
Event or Problem Description
It was reported that a guidewire break occurred.A 185cm pt2 guidewire was selected for use in a cardiac procedure.However, the wire broke inside the patient's body.No attempt was made to remove the broken portion.It was noted that the broken guidewire did not travel or move through the artery after the brake occurred.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.It was further reported that the pt2 guidewire was used for picc line purpose and was used for navigating.The guidewire broke near the clavicle.While trying to remove broken wire portion, wire was found near a side branch.The main branch flow remains ok, therefore it was not removed.
Event or Problem Description
It was reported that a guidewire break occurred.A 185cm pt2 guidewire was selected for use in a cardiac procedure.However, the wire broke inside the patient's body.No attempt was made to remove the broken portion.It was noted that the broken guidewire did not travel or move through the artery after the brake occurred.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.It was further reported that the pt2 guidewire was used for picc line purpose and was used for navigating.The guidewire broke near the clavicle.While trying to remove broken wire portion, wire was found near a side branch.The main branch flow remains ok, therefore it was not removed.

• 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: 9239566
• Report Number: 2134265-2019-12551
• Device Sequence Number: 16617557
• Product Code: DQX
• UDI-Device Identifier: 08714729471189
• UDI-Public: 08714729471189
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K030617
• 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): 11/22/2019

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: 10/30/2020
• Device Model Number: 2779
• Device Catalogue Number: 2779
• Device Lot Number: 0022867576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 10/26/2019; 11/19/2019
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 10/28/2019; 11/22/2019
• 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: Other