MAUDE Adverse Event Report: BALT EXTRUSION ECLIPSE2L BALLOON CATHETER; ECLISE2L

Model Number	ECL2L6X20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	07/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This reported complaint concerns a balt extrusion device.As legal manufacturer, balt extrusion is responsible for all postmarket activities including the investigation, root cause, and customer follow-up related to this complaint.Balt usa commercializes a similar device in the us market which is also manufactured by balt extrusion, and has initiated this complaint for the sole purposes of evaluation for potential reportability under united states mdr requirements.Balt usa reference # (b)(4).The investigation of the incident was performed legal manufacture balt extrusion, summary as follows: the affected catheter eclipse2l has not been returned to balt extrusion sas for inspection.As a result, the analysis of the reported event was by definition limited.The review was so based on the incident description, the device history records and the data gathered during our post-marketing surveillance program for such failures.The dhrs (device history records) review did not highlight any anomaly which could potentially explain the issue experienced during the procedure.During the manufacturing process, several tests are performed: the braid, the tube and the balloon are 100% controlled with a visual inspection.The balloons are 100% controlled during manufacturing with an inflating test ensuring that the balloon inflates evenly and symmetrically.A tightness test is performed on every ecl2l at the level of the catheter hub, the sleeve.The results of these different controls and steps conformed to the specifications.There is no similar complaint registered in our database to date on this lot number.The incident description mentioned that during the balloon inflation, only one side of the balloon inflated and this lead to the rupture of the vessel: "the distal part of the balloon get inflated, but not the proximal half of it.As the operator keep pushing in order to inflate the proximal part, the distal part get over inflated instead of the proximal, that keeps deflated.".Moreover, it has been reported that when the balloon was removed from the patient, the balloon had been checked and its inflated and deflated without any problem.This failure was probably caused by the vasculature angulation.The inflation issue observed can depend on the balloon position and so finally on the procedure conditions with the anatomical configuration and the device location when it is inflated.In this specific case, it has been reported that the anatomy was not particularly tortuous but the incident might be due to the angulation of the vessel.This position could have deformed the proximal part of the balloon, prevent its uniform inflation and cause the vessel rupture of the patient.As indicated in the ifu "mde052_ecl2l cop2l ind.7" §5.3 : "warning: inflate and deflate always the balloon while visualizing under fluoroscopy to ensure patient safety".Manufacturing records complied to specifications and product was not available for inspection.The most probable cause of the vessel rupture is related to anatomical conditions.Comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.At this time, no such increase in rate of occurrence has been observed, however this issue will remain subject to continued tracking as part of our post-marketing surveillance process.In conclusion, we cannot accurately determine the root cause experienced by the user since the affected device has not been returned to balt extrusion for investigation but, based on the information we had, the quality of the device does not seem to be involved since the balloon inflated and deflated correctly after pulling the eclipse2l out of the patient.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: "the balloon, after being correctly purged and inflated once in the area to be treated, failed to be inflated for the second time.The distal part of the balloon get inflated, but not the proximal half of it.As the operator keep pushing in order to inflate the proximal part, the distal part get over inflated instead of the proximal, that keeps deflated.Vassel break due to the balloon overinflation.Fortunately the patient survived and will probably recover." additional information received from the issuer: "they put the balloon on the trash, they said that the balloon was deformed as they manipulate it after the case (once out of the body of the patient).Honestly, i checked the balloon just after they pull it away and it inflate and deflate correctly.Some minutes after, the physicians manipulate it and after several time they put it on the trash." "they injected glue after the rupture of the vassel to stop the bleeding.The balloon did not rupture, the proximal part simply did not inflate.The proximal part was over-inflated but the balloon did not rupture." "just one unit of that batch number." "the hemorrhage was quickly stopped by the inr and the blood they found after on the tac was less than expected fortunately.The patient is recovering without any surgical intervention needed." "not much, the problem from my point of view was probably the angulation of the vessel.".

• Brand Name: ECLIPSE2L BALLOON CATHETER
• Common Device Name: ECLISE2L
• Manufacturer (Section D): BALT EXTRUSION; 10 rue de la coix vigneron; montmorency, 95160 ; FR 95160
• Manufacturer Contact: moises colin ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 14734034
• Report Number: 3014162263-2022-00018
• Device Sequence Number: 5595879
• Product Code: MJN
• UDI-Device Identifier: 00818053023002
• UDI-Public: 00818053023002
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K183045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/23/2022

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: 01/28/2026
• Device Model Number: ECL2L6X20
• Device Catalogue Number: N/A
• Device Lot Number: 00425182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown