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

Model Number MAGIC1,2FM

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2018

Event Type  malfunction  

Manufacturer Narrative

To whom it may concern: on (b)(6) 2018, balt extrusion received a complaint regarding the use of a single magic catheter.Details reported as follows: "two incidences involved.First case involved a catheter tip detaching during nbca injection.At time of this report, i did not get to speak to doctor directly.Info is second hand from technologist.Second case involved a catheter that technologist claimed was 'squirting out from the side of the catheter during prep.' product was not used in patient." 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.A leak on the magic microcatheter can be explained by a rupture caused by an overpressure.This overpressure is generally caused by a strong injection when a small syringe is used during the procedure.The ifu and label state that a syringe 2.5cc (ml) minimum must be used and that the maximum pressure allowed is 7 bars.Furthermore, clinical research has supported that breaks/detachments are common with this type of microcatheter.With limited information from the physician and through our investigation we were unable to determine root cause of the failure; however, studies have shown this failure mode can most likely be attributed to overpressure during injection.The magic microcatheters are 100% controlled with a 7 bars pressure test during manufacturing and a sampling is tested until bursting.No anomaly was observed for this lot number during the dhr review.Furthermore, the design verification tests showed that the product cannot be ruptured if the maximum pressure (7 bars) is respected.Email chain script: on (b)(6) 2018: complaint was received from (b)(6) for the following event: event date: (b)(6) 2018 & (b)(6) 2018.Institution: (b)(6).Complaint: two units involved, both the same lot # (magic 1.2 fm, 00299825).Event: two incidences involved.First case involved a catheter tip detaching during nbca injection.At time of this report, i did not get to speak to doctor directly.Info is second hand from technologist.Second case involved a catheter that technologist claimed was "squirting out from the side of the catheter during prep." product was not used in patient.On (b)(6) 2018: (b)(4) was issued to the complaint by (b)(4) via email to (b)(6).On 6/21/2018: balt usa, received rga package from (b)(6).On 6/29/2018: email was sent to (b)(4) advising that (b)(4) was going to be shipped via (b)(6).On 7/2/2018: (b)(4) email back with balt (b)(4) incident report reference (b)(4) for (b)(4), as well as follow up questions: we need additional information: regarding the magic1.2fm lot 00299825 ((b)(4)), for the first case, could you specify what do you mean by "a catheter tip detaching" ? could you specify which syringe was used ? did the doctor withdraw the whole microcatheter from the patient ? did nbca leak in the patient's vessel ? could you specify the patient outcome ? on 7/2/2018: email was sent to (b)(6) asking him to answer questions from (b)(4).On 7/3/2018: (b)(6) sent email with answers, stating no patient harm.Regarding the magic1.2fm lot 00299825 ((b)(4)), for the first case, could you specify what do you mean by "a catheter tip detaching" ? awaiting answer from physician.Could you specify which syringe was used? 3ml.Did the doctor withdraw the whole microcatheter from the patient? awaiting answer from physician.Did nbca leak in the patient's vessel? no.Could you specify the patient outcome? no harm to patient.On 7/23/2018: (b)(6) states in email "i have reached out to the physician several times and have not seen him in person recently.He has not responded to the two remaining questions.I will continue to seek him out and will provide answers once obtained." complaint was closed with no further information from the physician.(b)(4).

Event Description

It was reported that: "two incidences involved.First case involved a catheter tip detaching during nbca injection.At time of this report, i did not get to speak to doctor directly.Info is second hand from technologist.Second case involved a catheter that technologist claimed was 'squirting out from the side of the catheter during prep.' product was not used in patient.".

• Brand Name: MAGIC INFUSION CATHETER
• Type of Device: MAGIC
• Manufacturer (Section D): BALT USA, LLC; 29 parker; irvine CA 92618
• Manufacturer Contact: ryan breckenridge ; 29 parker; irvine 92618
• MDR Report Key: 8710127
• MDR Text Key: 151909395
• Report Number: 3014162263-2019-00006
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00818053022593
• UDI-Public: 00818053022593
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023351
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: MAGIC1,2FM
• Device Lot Number: 00299825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other