MAUDE Adverse Event Report: BALT USA BALLAST LONG SHEATH

Model Number	BALLAST90
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
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.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 lot history records did not reveal any in-process issue that could account for the observation.No additional complaints against lot number f201100330 has been made for the same issue.Comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.
Event or Problem Description
It was reported that: "tried gaining access with ballast via radial access and dilator tip was not smooth.Vessel was big enough for ballast but due to non smooth tip, dilator caught on radial artery.As he withdrew the sheath (needed to impart force to remove), the tip sheared off.No adverse patient impact." follow up recieved by sale representative on 23-apr-2021 confirmed that device broke inside vessel and was safetly retrieved.

• Brand Name: BALLAST LONG SHEATH
• Common Device Name: BALLAST
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• MDR Report Key: 11720737
• Report Number: 3014162263-2021-00018
• Device Sequence Number: 3591850
• Product Code: DQY
• UDI-Device Identifier: 00818053022890
• UDI-Public: 00818053022890
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2021

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: 11/25/2025
• Device Model Number: BALLAST90
• Device Catalogue Number: N/A
• Device Lot Number: F201100330
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2021
• Initial Report FDA Received Date: 04/23/2021
• 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