MAUDE Adverse Event Report: BALT USA HYBRID GUIDEWIRE

Model Number	HYBRID008D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa's reference number: (b)(4).Notice of complaint received via letter from fda on 09jun2022.Hospital submitted report through fda's medwatch program (mw5109809), incident not already recorded in balt usa database.Attempts made to obtain additional information from the issuer (as recorded in the medwatch report), however after 3 attempts, no response was provided.The investigation was performed by supplier, balt extrusion.A summary of the results is as follows: 30/06/2022: product not available for return.The affected device (hybrid008d) was not returned to balt extrusion for inspection.As a result, we could not perform a full analysis of the reported event.This analysis was based on the manufacturing records for this specific batch and the data issued from our post-marketing surveillance process.The lot history record (lhr) review did not highlight any anomaly that could explain the issue experienced by the user.Several tests are performed during the manufacturing process: - two different destructive tests by sampling are performed: wire twisting and bending - all units are tested with a non-destructive bending test.- the aspect of the weldings is 100% controlled.All tests mentioned above complied with the specifications for the affected lot number.Our database has registered no other complaint on this batch number.In the incident description it is mentioned that the" guide wire broke in the loop" we have limited information ,we assume that the device has not been introduced into the patient's body, based on the data gathered during our post-marketing surveillance program and the incident description, we can make the following hypothesis: - the issue could be explained by a wrong manipulation when removing the guide wire from the dispenser hoop (use of an excessive force).As mentioned in the ifu (directions for use section): "remove the guidewire from its protective dispenser hoop, taking special care with the distal part.If you have difficulty removing the guidewire, perfuse a sterile physiological saline solution into the protective dispenser.Examine the guidewire to make sure that it has not been damaged.Rinse the guidewire with the sterile physiological saline solution.If necessary, use the provided introducer to shape the guidewire to the desired shape." in conclusion, due to lack of information we were not able to accurately determine the origin of the event experienced.Hypotheses have been made but cannot be confirmed.However, the quality of the device does not seem to be involved as the review of the manufacturing records did not reveal any anomaly.Comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.At this time, no such increase in rate of occurrence has been observed.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 00426371 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
Notice of complaint received via letter from fda on 09jun2022.Hospital submitted report through fda's medwatch program (mw5109809), incident not already recorded in balt usa database.It was reported that: "guidewire broke in the loop.Fda safety report id # (b)(4).".

• Brand Name: HYBRID GUIDEWIRE
• Common Device Name: HYBRID
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• Manufacturer Contact: moises colin ; 29 parker; irvine, CA 92618 ; 9497881443
• MDR Report Key: 14956711
• Report Number: 3014162263-2022-00020
• Device Sequence Number: 2414145
• Product Code: DQX
• UDI-Device Identifier: 00818053022753
• UDI-Public: 00818053022753
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/01/2022

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 Expiration Date: 01/28/2026
• Device Model Number: HYBRID008D
• Device Lot Number: 00426371
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown