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

Model Number	81735
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire tip detachment and removal difficulties occurred.The 75% stenosed target lesion was located at the moderately tortuous and mildy calcified cephalic vein.A 135cm transend guidewire was tried to cross the lesion.The guidewire was tried to be inducted into the artery side of the anastomosis several times, but the device was unable to cross.So the guidewire was taken out from the body once and the shape was attached into the tip.The physician then tried to cross through the anastomosis part again, a black object was confirmed on the elbow part through the fluoroscopy.The guidewire was removed, and the tip of the guidewire was checked, no separation was observed.Therefore, another new guide wire was opened, and when the total length was compared, it was confirmed that the original length of the transend guidewire was about 1 cm shorter.During this time, a detached guidewire was confirmed.The elbow area was wrapped with clean gauze temporarily in preparation for removal of the detached guidewire.When imaging was performed with a simple computed tomography (ct) revealed the guidewire was around the papillary muscle near the right ventricle.The cardiologist then tried again to remove it with a snare, but it could not be removed.A cardiovascular surgeon was consulted and determined that it would be a considerable risk if it became an open chest surgery, so an observation was performed.The procedure was not completed due to this event.On the following day, when imaging was performed with a simple ct, the position of the detached part did not move.So the condition of the patient will be observed at the moment.No further patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mr.: unit returned in a generic plastic bag, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The returned device matches with upn and lot provided by the customer.The device was inspected and was found bent at distal tip and the distal section kinked.No other issues were observed in the device and no detached section were observed.Under inspection was possible to observed the polymer distal tip section detached.The outer diameter of the distal, middle and proximal sections of the device are within specifications.A pictures provided by the costumer were attached to the complaint record.In a photo shows the x-ray image where it is possible to observed the distal tip section detached.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.
Event or Problem Description
It was reported that guidewire tip detachment and removal difficulties occurred.The 75% stenosed target lesion was located at the moderately tortuous and mildy calcified cephalic vein.A 135cm transend guidewire was tried to cross the lesion.The guidewire was tried to be inducted into the artery side of the anastomosis several times, but the device was unable to cross.So the guidewire was taken out from the body once and the shape was attached into the tip.The physician then tried to cross through the anastomosis part again, a black object was confirmed on the elbow part through the fluoroscopy.The guidewire was removed, and the tip of the guidewire was checked, no separation was observed.Therefore, another new guide wire was opened, and when the total length was compared, it was confirmed that the original length of the transend guidewire was about 1 cm shorter.During this time, a detached guidewire was confirmed.The elbow area was wrapped with clean gauze temporarily in preparation for removal of the detached guidewire.When imaging was performed with a simple computed tomography (ct) revealed the guidewire was around the papillary muscle near the right ventricle.The cardiologist then tried again to remove it with a snare, but it could not be removed.A cardiovascular surgeon was consulted and determined that it would be a considerable risk if it became an open chest surgery, so an observation was performed.The procedure was not completed due to this event.On the following day, when imaging was performed with a simple ct, the position of the detached part did not move.So the condition of the patient will be observed at the moment.No further patient complications were reported.

• Brand Name: TRANSEND
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12917750
• Report Number: 2134265-2021-14565
• Device Sequence Number: 5271710
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2021

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: 08/30/2023
• Device Model Number: 81735
• Device Catalogue Number: 81735
• Device Lot Number: 0027934410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown