MAUDE Adverse Event Report: BALT USA ECLIPSE2L BALLOON CAHTETER

Model Number	ECL2L6X9
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa reference (b)(4).The investigation was performed by supplier balt extrusion.Summary provided as follows: the affected device (ecl2l 6x9) has been returned and inspected in our quality laboratory.During our analysis, we noticed that the catheter was ruptured and the braid of the catheter was severely stretched/damaged.- we observed the product returned in its secondary packaging; - we observed the embolic agent in the catheter; - we observed traces of blood on the stretched part of the catheter; - we observed the catheter to be ruptured and extremely stretched; - we observed the catheter to be stretched from 132cm (from the proximal extremity) to the end of the catheter.During our review of the lot history record (lhr) and the manufacturing process of the eclipse2l, we noted that: · the braid, the tube, and the balloon are 100% controlled with a visual inspection during the manufacturing process.· a tightness test of the balloon is also performed on every unit per manufacturing process instruction.· the integrity of the microcatheters is 100% controlled.We did not observe any anomaly that could potentially explain the reported issue.There is no other complaint registered on this lot number to date.The incident description mentioned that the eclipse2l was broken during injection of onyx: "the tip of the balloon was left behind and the catheter itself was extremely stretched." following the incident description, a reflux of onyx had been observed before the stuck of the catheter "then, a small amount of onyx refluxed around the balloon.[.] the balloon was deflated and upon removal the balloon was stuck.Based on our post-marketing surveillance program and information of incident description, fractures observed of the catheter are likely caused by the embolic agent reflux beyond the catheter's distal extremity during the injection, then unlikely linked to the eclipse2l device.In conclusion, the reported incident (rupture of the catheter after embolic agent trapping) cannot be linked to a potential technical failure of the balloon catheter eclipse2l.Manufacturing records complied with specifications, and the product was not available for inspection.A comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.No such increase in the rate of occurrence has been observed.However, this issue will remain subject to continued tracking.Review of the lot history records did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaints against lot number f220400657 has been made for the same issue.Comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.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 6x9 eclipse balloon was advanced over the synchro wire into distal branch just proximal to the fistula.The synchro wire was removed and dmso was injected into the working lumen, 0.3.The eclipse balloon was slightly inflated and onyx was delivered to the fistula without issue.Then, a small amount of onyx refluxed around the balloon.The embolization was largely completed within 7 minutes.The balloon was deflated and upon removal the balloon was stuck.Eventually, the balloon catheter was removed after a few minutes of pulling.The tip of the balloon was left behind and the catheter itself was extremely stretched.The tip of the balloon was left behind in the embolized vessel, so it was not of major concern.But, getting the balloon stuck so quickly was concerning in a 7 minute injection, said the physician.".

• Brand Name: ECLIPSE2L BALLOON CAHTETER
• Common Device Name: ECLIPSE2L
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• Manufacturer Contact: moises colin ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 15300829
• Report Number: 3014162263-2022-00024
• Device Sequence Number: 2467718
• Product Code: MJN
• UDI-Device Identifier: 00818053022944
• UDI-Public: 00818053022944
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 08/24/2022

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 Model Number: ECL2L6X9
• Device Catalogue Number: N/A
• Device Lot Number: F220400657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2022
• 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: Other
• Patient Sex: Unknown