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

Model Number MAGIC1,2F

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

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

Event Date 10/10/2018

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: "i was not present at the case, but on my visit to the hospital on (b)(6), dr.(b)(6) informed me that in the case on (b)(6) that one of the two magic catheters used ruptured near the tip.They did not save the catheter for inspection.Dr.(b)(6) commented that the rupture was so close to the tip, that it did not adversely effect the embolization or patient safety.Dr.(b)(6) shared the lot numbers with me, but was uncertain which of the two catheter stickers belonged to the catheter that ruptured.Dr.(b)(6) added that the physician who injected the glue used a 3cc medallion and that they did not have a lot of experience using glue." 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 Description

It was reported that: "i was not present at the case, but on my visit to the hospital on (b)(6), dr.(b)(6) informed me that in the case on (b)(6) that one of the two magic catheters used ruptured near the tip.They did not save the catheter for inspection.Dr.(b)(6) commented that the rupture was so close to the tip, that it did not adversely affect the embolization or patient safety.Dr.(b)(6) shared the lot numbers with me, but was uncertain which of the two catheter stickers belonged to the catheter that ruptured.Dr.(b)(6) added that the physician who injected the glue used a 3cc medallion and that they did not have a lot of experience using glue.".

Event Description

It was reported that: "i was not present at the case, but on my visit to the hospital on 10/11, dr.(b)(6) informed me that in the case on 10/10 that one of the two magic catheters used ruptured near the tip.They did not save the catheter for inspection.Dr.(b)(6) commented that the rupture was so close to the tip, that it did not adversely effect the embolization or patient safety.Dr.Hoss shared the lot numbers with me, but was uncertain which of the two catheter stickers belonged to the catheter that ruptured.Dr.(b)(6) added that the physician who injected the glue used a 3cc medallion and that they did not have a lot of experience using glue.".

Manufacturer Narrative

To whom it may concern: on october 11, 2018, balt extrusion received a complaint regarding the use of a single magic catheter.Details reported as follows: "i was not present at the case, but on my visit to the hospital on 10/11, dr.(b)(6) informed me that in the case on 10/10 that one of the two magic catheters used ruptured near the tip.They did not save the catheter for inspection.Dr.(b)(6) commented that the rupture was so close to the tip, that it did not adversely effect the embolization or patient safety.Dr.(b)(6) shared the lot numbers with me, but was uncertain which of the two catheter stickers belonged to the catheter that ruptured.Dr.(b)(6) added that the physician who injected the glue used a 3cc medallion and that they did not have a lot of experience using glue." 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.The product was not returned to balt extrusion facility for inspection.The precise lot number of the incriminated unit is not determined.As a result, we were not able to fully investigate the case.All magic microcatheters are controlled with a pressure test during the manufacturing process.The review of the lots 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 both lot numbers concerned 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.Finally, the welding processes between the different microcatheters tubes are also validated and the routine monitoring meets the requirements.From our experience, the distal 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 appropriate syringe size and/or to the microcatheter's lumen obstruction.It has been reported that a medallion 3cc syringe was used during the procedure.A 2.5cc minimum syringe with a piston diameter smaller than 10mm shall be used as indicated in the precautions of use in the ifu.The size of the syringe used complied with the ifu requirements but we do not have any information related to the piston diameter.It is also mentioned that the users did not have a lot of experience using glue.In conclusion, since the product was not returned for inspection, it is not possible to determine the accurate root cause.However, internal records conform to the specifications and our experience gained through the post-marketing surveillance process tends to demonstrate that this failure mode is generally caused by an overpressure above the maximum limit allowed.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.Attachment: [complaint no (b)(4)_analysis.Pdf].

Manufacturer Narrative

To whom it may concern: on october 11, 2018, balt extrusion received a complaint regarding the use of a single magic catheter.Details reported as follows: "i was not present at the case, but on my visit to the hospital on (b)(6), dr.(b)(6) informed me that in the case on (b)(6) that one of the two magic catheters used ruptured near the tip.They did not save the catheter for inspection.Dr.(b)(6) commented that the rupture was so close to the tip, that it did not adversely effect the embolization or patient safety.Dr.(b)(6) shared the lot numbers with me, but was uncertain which of the two catheter stickers belonged to the catheter that ruptured.Dr.(b)(6) added that the physician who injected the glue used a 3cc medallion and that they did not have a lot of experience using glue." 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.The product was not returned to balt extrusion facility for inspection.The precise lot number of the incriminated unit is not determined.As a result, we were not able to fully investigate the case.All magic microcatheters are controlled with a pressure test during the manufacturing process.The review of the lots 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 both lot numbers concerned 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.Finally, the welding processes between the different microcatheters tubes are also validated and the routine monitoring meets the requirements.From our experience, the distal 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 appropriate syringe size and/or to the microcatheter's lumen obstruction.It has been reported that a medallion 3cc syringe was used during the procedure.A 2.5cc minimum syringe with a piston diameter smaller than 10mm shall be used as indicated in the precautions of use in the ifu.The size of the syringe used complied with the ifu requirements but we do not have any information related to the piston diameter.It is also mentioned that the users did not have a lot of experience using glue.In conclusion, since the product was not returned for inspection, it is not possible to determine the accurate root cause.However, internal records conform to the specifications and our experience gained through the post-marketing surveillance process tends to demonstrate that this failure mode is generally caused by an overpressure above the maximum limit allowed.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 Description

It was reported that: "i was not present at the case, but on my visit to the hospital on (b)(6), dr.(b)(6) informed me that in the case on (b)(6) that one of the two magic catheters used ruptured near the tip.They did not save the catheter for inspection.Dr.(b)(6) commented that the rupture was so close to the tip, that it did not adversely effect the embolization or patient safety.Dr.(b)(6) shared the lot numbers with me, but was uncertain which of the two catheter stickers belonged to the catheter that ruptured.Dr.(b)(6) added that the physician who injected the glue used a 3cc medallion and that they did not have a lot of experience using glue.".

• Brand Name: MAGIC INFUSION CATHETER
• Type of Device: MAGIC
• Manufacturer (Section D): BALT USA, LLC; 29 parker; irvine, ca CA 92618
• MDR Report Key: 8735214
• MDR Text Key: 151913495
• Report Number: 3014162263-2019-00010
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00818053022586
• UDI-Public: 00818053022586
• Combination Product (y/n): N
• PMA/PMN Number: K023351
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: MAGIC1,2F
• Device Lot Number: 00303604, 00289757
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other