MAUDE Adverse Event Report: BALT USA, LLC MAGIC INFUSION CATHETER

Model Number	MAGIC1,2FM
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To whom it may concern: on july 18, 2018, balt extrusion received a complaint regarding the use of a single magic catheter.Details reported as follows: "i don't know any details on the case.The catheter tip broke in 3 pieces.Please replace catheter to hospital." the reported complaint was revisited and found unreported during and internal audit preformed by balt extrusion (balt usa's sister company).Complaint was then sent to balt usa to confirm whether the complication was deemed reportable.Balt usa has deemed it reportable due to a malfunction occurence that if to were reoccur could cause serious injury.Balt usa is waiting for analysis data from balt extrusion.Follow up report will be submitted within the next couple of weeks.
Event or Problem Description
It was reported that: "i don't know any details on the case.The catheter tip broke in 3 pieces.Please replace catheter to hospital.".
Additional Manufacturer Narrative
To whom it may concern: on july 18, 2018, balt extrusion received a complaint regarding the use of a single magic catheter.Details reported as follows: "i don't know any details on the case.The catheter tip broke in 3 pieces.Please replace catheter to hospital." the reported complaint was revisited and found unreported during and internal audit preformed by balt extrusion (balt usa's sister company).Complaint was then sent to balt usa to confirm whether the complication was deemed reportable.Balt usa has deemed it reportable due to a malfuction occurance that if to were reoccur could cause serious injury.The returned device was inspected in our quality laboratory with the support of the r&d and production teams.During our analysis, we observed that the magic microcatheter was ruptured at two levels on the white pursil distal part.The rupture sites are clean: there is no "bubble" shape and the tube is not stretched.We also noticed some dried brown residues that could be blood and/or embolic agent inside the white pursil lumen.All magic microcatheters are 100% controlled with a pressure test during the manufacturing process.The extruded tubes are also tested with tensile tests.The review of the lot history records did not highlight any anomaly that could potentially lead to the issue experienced by the user.There is no similar complaint registered on this lot number to date.In addition, the pressure resistance of the microcatheter magic is validated and this validation demonstrated that the devices cannot burst on the pressure range allowed as per indicated on the labels and in the ifu.The extrusion process is also validated and the results observed conformed to the specifications.Finally, the welding processes between the different microcatheters tubes are also validated and the routine monitoring meets the requirements.From our experience, the distal tubes ruptures are generally explained by an overpressure above the maximum 7-bars limit indicated on the label and in the instructions for use.This could be explained by a too strong injection that could be potentially linked to the use of an inappropriate syringe size and/or to the microcatheter's lumen obstruction.However, in this specific case, the tube did not show any "bubble" shape which is typical of an overpressure phenomena.This kind of issue could also be explained by an excessive traction applied on the device.However, as above-mentioned, the tube was not stretched which is typical of an excessive traction.Finally, one other hypothesis could be the inappropriate use of a mandrel as a navigation guidewire which represents a tubes perforation risk.We did not observe any anomaly on the mandrel distal extremity: it was well blunted and non-traumatic.In conclusion, we lack information to accurately determine the incident root causes.Additional questions were asked to the complainant but no answers were received at this stage.Different hypothesis have been established but they cannot be assuredly confirmed or not.See detailed narrative attached.The submission of this report or related information to the fda, and its release by fda, does not reflect a conclusion by the party submitting this report of the fda that the report or related information is an admission that the manufacturer, their employees, or the device caused or contributed to the reportable event.
Event or Problem Description
It was reported that: "i don't know any details on the case.The catheter tip broke in 3 pieces.Please replace catheter to hospital.".

• Brand Name: MAGIC INFUSION CATHETER
• Common Device Name: MAGIC
• Manufacturer (Section D): BALT USA, LLC; 29 parker; irvine CA 92618
• MDR Report Key: 8735215
• Report Number: 3014162263-2019-00011
• Device Sequence Number: 11330571
• Product Code: KRA
• UDI-Device Identifier: 00818053022593
• UDI-Public: 00818053022593
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K023351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2019

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: 02/28/2023
• Device Model Number: MAGIC1,2FM
• Device Lot Number: 00311998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Initial Date Received by Manufacturer: 01/18/2019
• Supplement Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 07/02/2019
• 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: Other