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

Model Number M001183020

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212)

Patient Problems Embolism (1829); Hyperventilation (1910); Device Embedded In Tissue or Plaque (3165)

Event Date 06/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that the tip detached and remained inside patient's body.The target lesion was located in the pulmonary artery.A 135/10 renegade¿ hi-flo¿ kit was selected for use.During procedure, it was noted that tip of the microcatheter stuck in a very small pulmonary artery.However, when the device was tried to remove, the tip broke off from the rest of the microcatheter and embolized to the brain.The detached tip remained in one of the arteries on the brain.The procedure was completed with a different device.No further patient complications were reported and patient¿s status was fine.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the patient went to cath lab for a procedure to balloon the left pulmonary artery and the aorta.Three hours into the procedure it was reported that the patient received a stent in the right pulmonary artery.After stenting of the right pulmonary artery difficulties occurred with the renegade catheter as the catheter became stuck within the artery.The physician forcefully withdrew the catheter resulting in the tip detaching within the patient.The physicians immediately began running scans to locate the detached tip.It was found imbedded in the patient¿s brain.Removal attempts were not made as the risks are far too much greater than to introduce a retrieval device through the patient¿s brain.The patient was left under anesthesia for 12 hrs.While gathering what the patient¿s prognosis will be now with the detached tip embedded into a vessel of the brain.As the patient was under anesthesia for 12 hours the patient began having desats and became tachypneic when the ventilator was attempted to be removed.The patient had difficulty breathing and is not able to be extubated.On (b)(6) 2018 the patient was seen by a neuro specialist to determine if there was any brain damage from the event and what problems the patient may experience throughout life as a result of the event.The patient is on anticoagulant medication to prevent that catheter tip from occluding and causing a stroke or seizure.It was further reported that the patient was extubated and sats were improving.It is undetermined if there has been any brain damage and the detached tip will be permanently left inside the patient.The patient is scheduled for further tests and a mri.

Event Description

It was further reported that this event was reported via medwatch # (b)(4).

Manufacturer Narrative

Updated: describe event or problem, other relevant history, device lot number, device expiration date, init reporter sent to fda, device manufactured date.Device evaluated by manufacturer: the manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.(b)(4).

• Brand Name: RENEGADE¿ HI-FLO¿ KIT
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 7642656
• MDR Text Key: 112492110
• Report Number: 2134265-2018-05966
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• PMA/PMN Number: K000177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: M001183020
• Device Catalogue Number: 18-302
• Device Lot Number: 20364964
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 3 MO