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

Model Number	81735
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that guide wire tip detachment occurred.The lesion was at anastomosis site of cephalic vein.The length of the lesion is approximately 1cm.There was no calcification.% of stenosis is unknown but it was severely stenosed.A 135cm model-"transend" guide wire was advanced to cross the lesion.However, it was noted that the tip of the guidewire got detached and had to be surgically removed.Since the detached guidewire tip was surgically removed the shunt was no longer able to be used.The shunt was then reconstructed at slightly central side.The procedure was successfully completed with a different sized device.The current patient condition is good.
Event or Problem Description
It was reported that guide wire tip detachment occurred.The lesion was at anastomosis site of cephalic vein.The length of the lesion is approximately 1cm.There was no calcification.% of stenosis is unknown but it was severely stenosed.A 135cm model-transend guide wire was advanced to cross the lesion.However, it was noted that the tip of the guidewire got detached and had to be surgically removed.Since the detached guidewire tip was surgically removed the shunt was no longer able to be used.The shunt was then reconstructed at slightly central side.The procedure was successfully completed with a different sized device.The current patient condition is good.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by mfr: the device was returned for analysis.The device is broken and the body has kinks along the body.The two pieces of device came back together, they were approximately 135 cm but they were too kinked to measure correctly.The outer diameters of the device sections were within specification.

• Brand Name: TRANSEND
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8232664
• Report Number: 2134265-2018-64952
• Device Sequence Number: 13506861
• Product Code: DQX
• UDI-Device Identifier: 08714729326274
• UDI-Public: 08714729326274
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K941710
• 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
• Report Date (Section B): 02/20/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/09/2020
• Device Model Number: 81735
• Device Catalogue Number: 81735
• Device Lot Number: 0021844918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 01/09/2019
• Supplement Report FDA Received Date: 02/20/2019
• 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