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

Model Number	2740
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guide wire tip detachment occurred.The target lesion was located in the distal right coronary artery (rca).After a non-bsc guide wire crossed the lesion, a 2.5x15mm non-bsc stent was advanced but it was unable to be delivered distally.The device was removed and the wire was switched to a 300 cm st mailman guide wire in order to help deliver the stent.The non-bsc stent was advanced and was deployed successfully.However, during removal of the 2.5x12mm catheter, it became stuck on the wire.The physicians pulled on the catheter and the wire was also stuck.As they continued to pull, the wire and the catheter came out but the tip of the wire was left in the rca.The physicians decided not to try to remove the broken wire tip and leave it in the rca and the procedure was completed.No patient complications were reported.The patient was fine and left the lab without any further incident.
Event or Problem Description
It was reported that guide wire tip detachment occurred.The target lesion was located in the distal right coronary artery (rca).After a non-bsc guide wire crossed the lesion, a 2.5x15mm non-bsc stent was advanced but it was unable to be delivered distally.The device was removed and the wire was switched to a 300 cm st mailman guide wire in order to help deliver the stent.The non-bsc stent was advanced and was deployed successfully.However, during removal of the 2.5x12mm catheter, it became stuck on the wire.The physicians pulled on the catheter and the wire was also stuck.As they continued to pull, the wire and the catheter came out but the tip of the wire was left in the rca.The physicians decided not to try to remove the broken wire tip and leave it in the rca and the procedure was completed.No patient complications were reported.The patient was fine and left the lab without any further incident.It was further reported that snaring was not attempted.
Additional Manufacturer Narrative
This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/14/2018 10:47 am ct.The report number is being corrected from: 2134265-2018-64218 to: 2134265-2018-62601.
Event or Problem Description
It was reported that guide wire tip detachment occurred.The target lesion was located in the distal right coronary artery (rca).After a non-bsc guide wire crossed the lesion, a 2.5x15mm non-bsc stent was advanced but it was unable to be delivered distally.The device was removed and the wire was switched to a 300 cm st mailman guide wire in order to help deliver the stent.The non-bsc stent was advanced and was deployed successfully.However, during removal of the 2.5x12mm catheter, it became stuck on the wire.The physicians pulled on the catheter and the wire was also stuck.As they continued to pull, the wire and the catheter came out but the tip of the wire was left in the rca.The physicians decided not to try to remove the broken wire tip and leave it in the rca and the procedure was completed.No patient complications were reported.The patient was fine and left the lab without any further incident.It was further reported that snaring was not attempted.The device was returned for analysis.Unit returned with its original pouch.The unit returned has one unknown catheter stuck in it, as part of overall visual revision.The device has its distal tip kinked, stretched and fractured.There are kinks at the distal section.The device came stuck in a secondary device.The outer diameter (od) of middle of the device and od of proximal section were within specification; however, the overall length and od of distal tip could not be performed because of the condition of the device (broken).

• Brand Name: MAILMAN
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8043279
• Report Number: 2134265-2018-62601
• Device Sequence Number: 19129639
• Product Code: DQX
• UDI-Device Identifier: 08714729165699
• UDI-Public: 08714729165699
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K964551
• 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,Followup
• Report Date (Section B): 01/25/2019

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: 03/09/2019
• Device Model Number: 2740
• Device Catalogue Number: 2740
• Device Lot Number: 0020384357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 11/06/2018; 11/30/2018
• Initial Report FDA Received Date: 11/06/2018
• Supplement Report FDA Received Date: 11/27/2018; 01/25/2019
• 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