MAUDE Adverse Event Report: BALT USA BALLAST LONG SHEATH

Model Number	BALLAST90
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Balt usa's reference number: (b)(4).An evaluation of the actual complaint sample could not be performed as the device was unavailable for return.Several follow up attempts were made with the hospital in order to obtain additional information on the incident and why it did not get reported to balt usa, but received no response from hospital.This includes the availability of the device for a device analysis to be performed.Based on the provided information, root cause could not be definitively determined.Lack of device return prevented deeper evaluation of the reported issue.Review of the dhr could not be conducted as the lot number of the ballast90 unit was not reported.
Event or Problem Description
Notice of complaint received via letter from fda on 31aug2021.Uf/importer report # (b)(4): it was reported that: "when the procedure was over, the ballast 088 long sheath (ballast90) was being removed from the radial artery of the patient when the artery developed spasm.While being removed, the catheter broke and a fragment of the catheter was left intravascularly inside the radial artery of the patient.

• Brand Name: BALLAST LONG SHEATH
• Common Device Name: BALLAST
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• MDR Report Key: 12537675
• Report Number: 3014162263-2021-00031
• Device Sequence Number: 13738298
• Product Code: DQY
• UDI-Device Identifier: 00818053022890
• UDI-Public: 00818053022890
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K182918
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2021

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 Model Number: BALLAST90
• Device Catalogue Number: N/A
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2021
• Initial Report FDA Received Date: 09/27/2021
• 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