MAUDE Adverse Event Report: BALT EXTRUSION ECLIPSE2L BALLOON CATHETER

Model Number	ECL2L6X9
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This reported complaint concerns a balt extrusion device.As legal manufacturer, balt extrusion is responsible for the all post-market 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's reference number: (b)(4).Balt extrusion analysis: the affected catheter has been returned and inspected in our quality laboratory with the support of the engineering teams.During our analysis, we observed the balloon under binocular, any deformation does not detected but we observed that the proximal balloon welding was delaminated.Then, we inflated the balloon of the eclipse2l and we noticed a longitudinal cut on the area delaminated.The balloons are 100% controlled during the manufacturing process with a visual inspection and a tightness test.A 100% visual inspection on the appearance of the balloon is also performed after the hydrophilic coating is applied.The review of the manufacturing records of this specific batch number did not reveals any issue that could potentially contribute to the issue experienced by the user.No similar complaint is registered to date on this eclipse2l lot number in our database.We could not accurately determine the origin of the delamination of the weld and the longitudinal cut observed during our investigations.An hypothesis could be an improper manipulation of the device during the preparation with an excessive injection in the balloon.As indicated in the instructions for use: "do not exceed the maximum recommended inflation volume as balloon rupture may occur." however, we do not precisely know the conditions of the procedure and we cannot conclude at the evidence of this hypothesis.A second hypothesis could be an interaction during the manufacturing process with the purge wires that could have drilled the balloon and/or an improper balloon welding.A global corrective action to better apprehend the leakage failure on eclipse2l product range has been opened on our side.In conclusion, we were not able to accurately determine the origin of the event experienced.Some hypotheses have been established but they cannot be confirmed at this stage.The trend of this failure mode will be reviewed during our post-marketing surveillance process.
Event or Problem Description
It was reported that: "balloon deformed from packaging - catheter tip bent.Classified as atraumatic after inspection by an interventionalist, thus finally introduced into the patient and tried to inflate, this was not possible after it was found that the balloon might have a leak.No consequences here, except delay in neurointervention.Possible consequences: difficulties in recovering the catheter; falsified examination result" follow up (04-feb-2021) *decision to report: "we further analyzed and evaluated again the risk "inflation issue" during use in the patient with the support of r&d, regulatory and clinical affairs departments and one of our experts, professor (b)(6), head of neuroradiology department of (b)(6).This study allowed us to adjust our risk analysis documentation following our internal risk process by adding more clarification to the hazardous situation "balloon leakage" with addition of a potential harms in case the inflation issue would occur during an emergency procedure.As mentioned in the instructions for use, the balloon is used to protect the vessels by temporary occlusion.In very specific situations, which have never been reported to us during the 5 years of marketing of the product, the problem of inflation of the balloon due to a leak can lead to a serious deterioration of the patient's state of health.Indeed, the functional deficiency of the balloon can lead to a difficult situation for the physician to manage as the balloon protection cannot be guaranteed anymore in case for example of embolus migration (ischemic stroke) or hemorrhage (hemorrhagic stroke) and can then cause clinical complications for the patient.This risk of lack of balloon inflation is taken into account in our risk management file but not linked to these harms.".

• Brand Name: ECLIPSE2L BALLOON CATHETER
• Common Device Name: ECLIPSE2L
• Manufacturer (Section D): BALT EXTRUSION; 10 rue de la croix vigneron; montmorency, 95160 ; FR 95160
• MDR Report Key: 11333789
• Report Number: 3014162263-2020-00045
• Device Sequence Number: 3416513
• Product Code: MJN
• UDI-Device Identifier: 00818053022944
• UDI-Public: 00818053022944
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K183045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/08/2021

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: 08/28/2022
• Device Model Number: ECL2L6X9
• Device Catalogue Number: N/A
• Device Lot Number: 00292127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 02/16/2021
• 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