MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DIREXION HI-FLO; CATHETER, CONTINUOUS FLUSH

Model Number	80619
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter name and address: (b)(6).
Event or Problem Description
It was reported that catheter was fluffing.The target lesion was located in a moderately tortuous internal iliac artery.A direxion hi-flo was selected for use.After removal from the body, a "fluffing" was seen outside the catheter.No patient complications were reported.
Additional Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The device shaft was analyzed for any damage.The devices shaft showed damage in the form of a fracture located 31.5cm from the hub.The fracture looked to be consistent with a tensile force breaking.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
Event or Problem Description
It was reported that catheter was fluffing.The target lesion was located in a moderately tortuous internal iliac artery.A direxion hi-flo was selected for use.After removal from the body, a "fluffing" was seen outside the catheter.No patient complications were reported.It was further reported that the distal part of the catheter shaft lifted.The issue was visible as it occurred outside of the catheter shaft.Also, there was no difficulty encountered upon removal as the device was removed in the usual way.

• Brand Name: DIREXION HI-FLO
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12180280
• Report Number: 2134265-2021-09076
• Device Sequence Number: 911316
• Product Code: KRA
• UDI-Device Identifier: 08714729839484
• UDI-Public: 08714729839484
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/23/2021

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: 04/22/2023
• Device Model Number: 80619
• Device Catalogue Number: 80619
• Device Lot Number: 0027190720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1