MAUDE Adverse Event Report: BALT USA BALLAST 088 LONG SHEATH

Model Number	BALLAST90
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	09/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: "(b)(6) female, thrombectomy patient.Went radial (infuse cocktail through 6f sheath, then exchange to ballast) and started experiencing vasospasm.Then went femoral and gave cocktail; nitro, verapamil & cardiac lido (waited an hour) tried several others.Tried several techniques and finally had vascular removed." follow up 29sep2021: "i asked if there was any major injury from this and they said the arm was saved but there was an arm bypass done to remove the sheath." "no, no reported malfunction.They think the patient just had severe vasospasm, which caused it." "the patient did have to go to surgery to have an arm bypass done to remove the sheath.".
Additional Manufacturer Narrative
(b)(4).An evaluation of the actual complaint sample could not be performed as the device was unavailable for return.Follow up with the issuer revealed that there was no device malfunction (harm unrelated to the device).Based on the provided information, root cause could not be definitively determined.Lack of device return prevented deeper evaluation of the reported issue.Dhr review could not be performed since the product lot number was unavailable and not reported.

• Brand Name: BALLAST 088 LONG SHEATH
• Common Device Name: BALLAST
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• MDR Report Key: 12701423
• Report Number: 3014162263-2021-00035
• Device Sequence Number: 19945084
• 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: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 09/28/2021
• Initial Report FDA Received Date: 10/26/2021
• 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