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

Model Number	84590
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that resistance was noted when withdrawing the catheter.The 50% stenosed target lesion was located in the not so tortuous and mildly calcified ulnar artery.A direxion transend-14 system was selected for use.Delivery was made using the microcatheter and a continuous saline flush was maintained between the guiding catheter and the microcatheter, and between the microcatheter and the guidewire during the procedure.During withdrawal, it was noted that there was resistance in withdrawing the direxion microcatheter.The device was removed along with the 5f diagnostic catheter and the procedure was completed with a different device.It was noted that excessive force was not required.No patient complications were reported and patient was stable post procedure.
Event or Problem Description
It was reported that resistance was noted when withdrawing the catheter.The 50% stenosed target lesion was located in the not so tortuous and mildly calcified ulnar artery.A direxion transend-14 system was selected for use.Delivery was made using the microcatheter and a continuous saline flush was maintained between the guiding catheter and the microcatheter, and between the microcatheter and the guidewire during the procedure.There was not so much resistance/friction experienced which required excessive force.The microcatheter and other devices were sufficiently flushed and hydrated throughout the procedure.During withdrawal, it was noted that there was resistance in withdrawing the direxion microcatheter.The device was removed along with the 5f diagnostic catheter and the procedure was completed with a different device.No patient complications were reported and patient was stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the device was returned for evaluation.The device was inspected for any damage or irregularities.The direxion showed damage in the form of a separation located at the hub.The hub was completely separated and not returned for analysis.Multiple stretching, kinks and fractures were seen the length of the catheter.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage.Device analysis determined the condition of the returned device was not consistent with the reported information of jammed.Because there was no evidence of any product quality deficiencies, it was considered likely that the kinks, stretching and fractures were attributable to procedural issues.

• 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
• MDR Report Key: 11366855
• Report Number: 2134265-2021-02116
• Device Sequence Number: 1112785
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

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: 09/07/2022
• Device Model Number: 84590
• Device Catalogue Number: 84590
• Device Lot Number: 0025976289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 61