MAUDE Adverse Event Report: BALT USA, LLC ECLIPSE2L

Model Number	ECL2L6X12
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	03/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending device evaluation.
Event or Problem Description
It was reported that: "used balloon for d fistula.After final injection of onyx dr.Tried pulling eclipse out of onyx cast.There was some reflux around the balloon.Balloon tip broke off and a stream of onyx presented in the vert.He tried removing it with penumbra section, he tried snaring it out, he tried tacking it with a wingspan stent.Ended up sucking the vert with a plug.".
Event or Problem Description
It was reported that: "used balloon for d fistula.After final injection of onyx dr.Tried pulling eclipse out of onyx cast.There was some reflux around the balloon.Balloon tip broke off and a stream of onyx presented in the vert.He tried removing it with penumbra section, he tried snaring it out, he tried tacking it with a wingspan stent.Ended up sucking the vert with a plug.".
Additional Manufacturer Narrative
To whom it may concern: on march 13, 2020, balt usa received a complaint regarding the use of a single eclipse2l balloon catheter.Details reported as follows: "used balloon for d fistula.After final injection of onyx dr.Tried pulling eclipse out of onyx cast.There was some reflux around the balloon.Balloon tip broke off and a stream of onyx presented in the vert.He tried removing it with penumbra section, he tried snaring it out, he tried tacking it with a wingspan stent.Ended up sucking the vert with a plug." as of march 19, 2020 physician reported that patient was doing fine.The results of our investigation, are summarized as follows: the affected balloon catheter eclipse2l returned to balt extrusion was inspected with the support of the engineering teams.We noticed that the tubing and the braiding were severely damaged and stretched.The distal extremity with the balloon and rings were not present since the catheter broke during the removal attempts as per explained in the incident description.The braiding, the tubing, 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 as per requested by the manufacturing instructions.By reviewing the manufacturing records of this specific batch, we did not observe any anomaly that could potentially explain the event described : a process deviation #(b)(4) related to intermediate tubing length was applied for this specific lot number but it did not represent any technical link with the failures from this complaint; no similar complaint is registered to date on this lot number in our database.The eclipse2l revealed being entrapped into the embolic agent injected ("after final injection of onyx dr.Tried pulling eclipse out of onyx cast.There was some reflux around the balloon").We do not know accurately the conditions where occurred this issue and which manipulations were applied.However, the data issued from our post-marketing surveillance program show that such blocking are generally caused by the embolic agent reflux beyond the catheter's distal extremity.Finally, this incident type cannot be linked to the device itself since there is not a technical characteristic that could explain the trapping.We suggest you to contact the embolic agent manufacturer for additional information for such a failure (e.G.Poor visualization of the reflux on the x-ray pictures).The damages above-mentioned could assuredly be linked with the removal attempts after the device was entrapped within the embolic agent plug.In conclusion, the incident reported (embolic agent trapping) cannot be linked to a potential technical failure of the balloon catheter eclipse2l.Manufacturing records complied to specifications and product was severely damaged for a proper inspection.The trend of this failure mode will continue to be monitored as part of our post-marketing surveillance program.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.
Additional Manufacturer Narrative
Pending device evaluation.Due to covid-19 concerns it has been increasing difficult for balt usa's sister company, balt extrusion, to perform the analysis of the returned device.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: "used balloon for d fistula.After final injection of onyx dr.Tried pulling eclipse out of onyx cast.There was some reflux around the balloon.Balloon tip broke off and a stream of onyx presented in the vert.He tried removing it with penumbra section, he tried snaring it out, he tried tacking it with a wingspan stent.Ended up sucking the vert with a plug.".

• Brand Name: ECLIPSE2L
• Common Device Name: ECLIPSE2L
• Manufacturer (Section D): BALT USA, LLC; 29 parker; irvine, ca
• MDR Report Key: 9944369
• Report Number: 3014162263-2020-00008
• Device Sequence Number: 11577567
• Product Code: MJN
• UDI-Device Identifier: 00818053022968
• UDI-Public: 00818053022968
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K183045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2020

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: 01/08/2021
• Device Model Number: ECL2L6X12
• Device Catalogue Number: N/A
• Device Lot Number: F200100037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Initial Date Received by Manufacturer: 03/13/2020
• Supplement Date Received by Manufacturer: 03/13/2020; 03/13/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 05/07/2020; 05/12/2020
• 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: Required Intervention