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

Model Number UNK783

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: the device was returned for analysis.Returned product consisted of a direxion micro-catheter with a.016 guidewire stuck in the device.The shaft was microscopically examined.The device showed 1 separation on the nickel shaft.The separation was located 39cm from the hub.No other damage was noticed on the shaft.The device was not completely separated the inner liner was intact.The inner liner showed multiple areas of constriction along the catheter shaft.The guidewire that was stuck in the device was most likely stuck because of the stretched/constriction of the inner liner.There was no evidence of a perforation or hole in the device.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

It was reported that the catheter tip was punctured.The target area was located in the mildly tortuous and mildly calcified gastrointestinal (gi) tract.A direxion hi-flo was selected for use.During a gi bleed embolization procedure, it was noted that the direxion microcatheter was sticking when entering the non bsc guide catheter.Furthermore, when the direxion was taken out, the catheter became stretched and the lumen lost its integrity.After retrieval, a puncture was noted on the tip of the direxion catheter.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was okay.

• Brand Name: DIREXION HI-FLO
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7768683
• MDR Text Key: 116710868
• Report Number: 2134265-2018-07105
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K132947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1