MAUDE Adverse Event Report: BALT USA ECLIPSE2L BALLOON CATHETER

Model Number	ECL2L6X20
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa's reference number: (b)(4).Pending on investigation findings from supplier balt extrusion.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 physician was post dilating a surpass and he could not get the eclipse to deflate.The tech called me and i asked them to pull tension on the balloon and try to deflate.The balloon came down and is available to return.He finished the case with a transform balloon.".
Additional Manufacturer Narrative
Balt usa's reference number: (b)(4).The returned product was sent to supplier balt extrusion for deeper investigation, summary provided as follows: 1/the returned product was inspected in our quality laboratory with the support of the engineering teams.After analysis under binocular, we noted that the braid was not damaged and that the tubes were not collapsed.We tried to inflate and to deflate the balloon and we succeeded to do so without any specific difficulty.No anomaly was observed on the balloon shape and the deflation time was not longer than usual (see pictures attached for illustration).As a result, we were not able to reproduce the failure mode experienced by the user on our side.The returned product was sent to supplier balt extrusion for deeper investigation, summary provided as follows: 2/during our review of device history records (dhrs) and process of the eclipse2l, we noted that: the balloons are 100% controlled during manufacturing with an inflating test.The tubes integrity is also 100% controlled with a visual inspection before the packaging into protective dispensers.We did not observe any anomaly that could potentially explain the event described in the dhr.Our documentary record review also showed: a process deviation pd12060 applied for this specific lot number and was related to cleaning of the outer surface of the dispensers before the insertion of the magic and ecl2l: this has no technical link with the complaint #899; finally, no similar complaint had been reported for this lot number.3/the deflation failure could depend on the balloon position and so finally on the procedure conditions with the anatomical configuration and the device location when it is inflated and deflated.In this specific case, the balt sales representative indicated us that the patient anatomy was fairly tortuouse and he advised to user to "pull tension on the ballon and try to deflate"; the balloon came down and had been retrieved.In some configurations, with a proximal part of the balloon located in a tortuous segment, deflation could be made more difficult than usual.The ifu explains "viscosity and concentration of contrast mixture affect balloon inflation and deflation times".In this specific case, "the balloon was set up with 70/30 contrast saline".This proportion could have affected the deflation especially with the hypothese mentioned above.In conclusion, the results of the investigations led to show that this incident could have been caused by the procedure's conditions: anatomical configuration.This phenomena could have been also reinforced by an excessively viscous mixture due to the significant ratio of contrast inside.Failure was not reproduceable on our side, the returned product inspection did not reveal any anomaly, as well as the review of the manufacturing records.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 physician was post dilating a surpass and he could not get the eclipse to deflate.The tech called me and i asked them to pull tension on the ballon and try to deflate.The balloon came down and is available to return.He finished the case with a transform balloon.".

• Brand Name: ECLIPSE2L BALLOON CATHETER
• Common Device Name: ECLIPSE2L
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• MDR Report Key: 11755436
• Report Number: 3014162263-2021-00019
• Device Sequence Number: 19631391
• Product Code: MJN
• UDI-Device Identifier: 00818053023002
• UDI-Public: 00818053023002
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2021

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: 10/06/2021
• Device Model Number: ECL2L6X20
• Device Catalogue Number: N/A
• Device Lot Number: F201000108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 10/06/2021
• 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