MAUDE Adverse Event Report: BALT USA MAGIC; INFUSION CATHETER

Model Number	MAGIC1,2FM
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Death (1802)
Type of Reportable Event	Death
Additional Manufacturer Narrative
The magic m 1.2fr 165cm was not returned for evaluation.The device is being retained by the hospital until further notice.Therefore; an analysis could not be performed.Based on the available information the root cause of this complaint was due to incorrect use of the device.Both ifu and label state the following; the magic micro-catheters are not compatible with embolization agents containing dmso or methyl metacrylate (as eudragit®).In conclusion, the most probable cause at the origin of this incident is due to the use of the magic catheter with a dmso product.Review of the lot history records for the reported lot did not reveal any in-process or lot-specific issue that could account for the observation.
Event or Problem Description
Medwatch report was received via us mail on august 8, 2019.During embolization of an arteriovenous malformation (avm} with onyx, staff noted the onyx was leaking out of the mid-portion of the magic 1, 2fm catheter during the 3rd injection.The onyx should exit the catheter at the tip, not from the mid-portion.The physician had to employ a solitaire device and use aspiration to retrieve the onyx.Per the op note, approximately 60% was recaptured.A 2nd physician was called in to assist.Mds worked approximately 2.5 hours to correct the issue.Attempts were eventually stopped to prevent further harm to the patient.As a result of the event, the patient has a large right frontal stroke.Since the event, he has developed an intracranial hemorrhage requiring a craniectomy for decompression & hematoma evacuation.He remains in icu with a poor neurological exam and poor prognosis.What was the original intended procedure? : per staff report, the onxy is injected via the magic l,2fm catheter.It should exit the catheter at the tip end, not from the mid-portion.The catheter was retained.What problem did the user have (check all that apply} :device failed (e.G.Broke, couldn't get it to work or stopped working) ; other relevant history, including preexisting medical conditions (e.G.Allergies, pregnancy, smoking and alcohol use, liver/kidney problems, etc.) preexisting characteristics that may have contributed to the event: hypertension; stroke; hepatic/renal dysfunction; diabetes; 08/09/2019- follow up email was sent to (b)(6) requesting device availability and patient status.08/12/2019-follow up replied email was received from (b)(6) stating the device was going to be retained by hospital.08/12/2019-follow up email sent out to (b)(6) inquiring patient status.08/16/2019- follow up replied email was received from (b)(6) stating patient had expired.08/16/2019 follow up email sent to (b)(6) requesting patient expiration date.8/19/2019-follow up replied email received from (b)(6) patient expired (b)(6) 2019.

• Brand Name: MAGIC
• Common Device Name: INFUSION CATHETER
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• MDR Report Key: 8928471
• Report Number: 3014162263-2019-00014
• Device Sequence Number: 13965222
• Product Code: KRA
• UDI-Device Identifier: 00818053022593
• UDI-Public: 00818053022593
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K023351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2022
• Device Model Number: MAGIC1,2FM
• Device Catalogue Number: MAGIC M 1.2FR 165CM
• Device Lot Number: 00302942
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 44 YR