MAUDE Adverse Event Report: BALT EXTRUSION HYBRID GUIDEWIRE

Model Number	HYBRID1214D
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pending on investigation findings from supplier balt extrusion.
Event or Problem Description
Report sent to fda by user facility: "during the first manoeuvre to raise the balloon (eclipse 6x12), to position it in front of the deck of the anevrysm (manoeuvring that were question) we noticed that the guide dit not respond, neither with torque nor while with drawing it.Due to the above, we decided to remove the balloon from the patient.Once outside, we could see that the guide was broke, probably due/ on a transition zone, and had divided in two fragments.After this incident, we hand another guide with the same balloon-catheter and the ".Technique" could be done without any problem, with this new guide." to fully investigate this case, could you respond at the following questions: -could you please check the incident description that we record on the doc enclosed and correct this if necessary? (it was difficult to me to be sure to understand the information of the incident form) correct -could you please send us the name of the hospital affected by this incident? (b)(6).-could you please tell me when the affected product will sent to balt extrusion? it has been sent already to balt extrusion -could you please tell me what it the characteristic of the patient anatomy (tortuous or not)? normal anatomy -where did the device break and was it within a secondary device or not? not -what is meant by "the guide did not respond" from the incident description? it means the guide did not do what they wanted, torque, [?].-where was the device located when it stopped functioning? i don not know.
Event or Problem Description
Report sent to fda by user facility: "during the first manoeuvre to raise the balloon (eclipse 6x12), to position it in front of the deck of the anevrysm (manoeuvring that were question) we noticed that the guide dit not respond, neither with torque nor while with drawing it.Due to the above, we decided to remove the balloon from the patient.Once outside, we could see that the guide was broke, probably due/ on a transition zone, and had divided in two fragments.After this incident, we hand another guide with the same balloon-catheter and the ".Technique" could be done without any problem, with this new guide." to fully investigate this case, could you respond at the following questions: -could you please check the incident description that we record on the doc enclosed and correct this if necessary? (it was difficult to me to be sure to understand the information of the incident form) correct -could you please send us the name of the hospital affected by this incident? (b)(6)-could you please tell me when the affected product will sent to balt extrusion? it has been sent already to balt extrusion -could you please tell me what it the characteristic of the patient anatomy (tortuous or not)? normal anatomy -where did the device break and was it within a secondary device or not? not -what is meant by "the guide did not respond" from the incident description? it means the guide did not do what they wanted, torque, [?].-where was the device located when it stopped functioning? i don not know.
Additional Manufacturer Narrative
This reported complaint concerns a balt extrusion device.As legal manufacturer, balt extrusion is responsible for the 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.08mar2022: review of open complaints within balt usa database revealed that this record has been closed in supplier balt extrusion's qms, therefore investigation results have been updated accordingly.Balt usa reference (b)(4).The returned product was sent to legal manufacturer balt extrusion, summary of investigation as follows: the affected guide-wire (hybrid) has been returned and inspected in our quality laboratory with the support of the engineering teams.During our analysis, we observed the guide-wire was ruptured at the level of the welding between the nitinol and the stainless-steel parts.The rupture is perfectly clean and we did not observed any anomaly on the welding linked to manufacturing.The review of the lhrs (lot history records) for this specific batch number did not highlight any anomaly during the manufacturing process.The in-process controls performed on the welding conformed to their specifications: · destructive testing by sampling: wire twisting ; · destructive testing by sampling: wire bending ; · 100% control of the welding visual aspect ; · 100% control of the welding diameter ; · all units are tested with a non-destructive bending test.There is no similar complaints on this lot number.Based on the data gathered during our post-marketing surveillance program, the issue could be due to an excessive traction, bending or twisting of the device.As mentioned in the ifu mde020_hybrid ind.15 (see § 5."directions for use" and § 6.1 "precautions for use"): · "avoid repeated bending, at the same point in order to avoid damage or separation of the guidewire"; · "remove the guidewire slowly once the goal has been reached"; · "never force an intravascular device against resistance without first determining the cause through angiographic inspection.Working against resistance can damage the guidewire and the catheter or cause lesions in the patient".In conclusion, the root-cause of this issue cannot be accurately determined.Yet, this issue will remain subject to continued tracking as part of our post-marketing surveillance process.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.

• Brand Name: HYBRID GUIDEWIRE
• Common Device Name: HYBRID
• Manufacturer (Section D): BALT EXTRUSION; 10 reu de la croix vigneron; montmorency, CA 95160 ; FR 95160
• Manufacturer Contact: moises colin ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 11904402
• Report Number: 3014162263-2021-00021
• Device Sequence Number: 4163966
• Product Code: DQX
• UDI-Device Identifier: 00818053022784
• UDI-Public: 00818053022784
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K182337
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2021
• 2 Devices were Involved in the Event: 1 2

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: HYBRID1214D
• Device Lot Number: 00389432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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