MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DIREXION TRANSEND-14 SYSTEM; CATHETER, CONTINUOUS FLUSH

Model Number	84590
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 03may2022.It was reported that the device could not track on diagnostic catheter.Vascular access was obtained via the femoral artery.The target lesion was located in the gastrointestinal area.A 130cm direxion transend-14 system was selected for use.The device was hydrated 15 seconds prior to removal of the hoop.Upon introduction, the device could not track on diagnostic catheter.The procedure was completed with another of same device.No complications were reported and patient was stable post procedure.However, device analysis revealed that the device was fractured 66.7cm from the hub.
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The device was inspected for any damage or irregularities.The direxion was received with the guidewire still fully inserted.The direxion was hydrated, and the guidewire was removed with extreme care due to the kinks and fracture.The device was inspected for kinks or damage, kinks were noted 4.5 cm, 4.7 cm, and 6.4 cm from the tip.A fracture was confirmed 66.7 cm from the hub.The shaft was not completely separated, the inner liner was still intact.The fracture looked consistent with a bending and tensile force breaking.The catheter had signs of stretching along the entire length and measured 61.5 cm to the tip.The device was not introduced into a guide catheter due to the kinks and fracture.Device analysis determined the condition of the returned device was consistent with the reported complaint of difficult to insert.

• Brand Name: DIREXION TRANSEND-14 SYSTEM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14475568
• Report Number: 2134265-2022-05799
• Device Sequence Number: 11945853
• Product Code: KRA
• UDI-Device Identifier: 08714729839743
• UDI-Public: 08714729839743
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K142259
• 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
• Report Date (Section B): 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/18/2023
• Device Model Number: 84590
• Device Catalogue Number: 84590
• Device Lot Number: 0027517017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2021
• 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
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Weight: 51 KG