MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DIREXION HI-FLO FATHOM-16 SYSTEM; CATHETER, CONTINUOUS FLUSH

Model Number	84591
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of a direxion hi flo microcatheter with a cordis 5f guide catheter.The cordis device was measured with a calibrated plug gage and each end had an inner diameter measuring.035 inches.Inspection revealed tip damage (bent/compressed), outer shaft separation located 82cm from the tip with the inner shaft stretched for 35.5cm in between the separated outer, and the inner shaft was also damaged (stretched and then compressed) for approximately 3cm starting behind the tip of the device.There was no other damage to the device.The direxion tip could not load into the cordis guide.The direxion undamaged area was measured with a calibrated micrometer, and the undamaged area was.037 inches, and the damaged portion of the device measured.041 inches.
Event or Problem Description
Reportable based on device analysis completed on 16sep2019.It was reported that device was stuck.A 027/straight/1ro/130 direxion hi-flo fathom 16 was selected for use.During the procedure inside the patient, it was noted that the catheter was stuck in the lumen of a non-bsc device.However, device analysis revealed that the outer shaft was separated about 82 cm from the tip.

• Brand Name: DIREXION HI-FLO FATHOM-16 SYSTEM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9179157
• Report Number: 2134265-2019-12074
• Device Sequence Number: 2657466
• Product Code: KRA
• UDI-Device Identifier: 08714729839682
• UDI-Public: 08714729839682
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K142259
• 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
• Report Date (Section B): 10/11/2019

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: 10/10/2020
• Device Model Number: 84591
• Device Catalogue Number: 84591
• Device Lot Number: 0022779866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1