MAUDE Adverse Event Report: BALT USA, LLC BALLAST LONG SHEATH

Model Number	BALLAST90
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	08/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To whom it may concern: visual analysis of the ballast long sheath revealed the sheath broken into two separate pieces, approximately 46cm from the hub.The distal section of the sheath had approximately 6.2cm of winding coil protruding out.There was break 13cm into the distal section of the sheath, with unknown calcification formed around the break.Based on the available information and the investigation results the complaint is confirmed.Its believed that the unknown calcification and possible venospasms caused the sheath to lock in place within the radial artery.As the physician attempted to free the device, the sheath was exposed to a force greater than its tensile strength causing it to fracture into two separate pieces.Venospasms and calcification are not uncommon with these type of procedures.Patient's anatomy are well understood complications and are not infrequent nor unique to balt usa products, having an established history of occurrence across similar marketed devices for many years.Review of the lot history records for the reported lots did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaints against lot number 062019d 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: "dr.(b)(6) was performing a basilar arterial thrombectomy in an acute stroke case.He used the ballast 90 through the radial artery to access the vertebral artery.When removing the ballast post thrombectomy the experience a large amount of friction.This friction resulted in the ballast tip fracturing off and remaining in the radial artery.The patient required vascular resection for removal and repair of the radial artery.The physician notice a large amount of unknown calcification in the radial artery during the resection.He believes the large amount of friction on removal of the ballast was created by this calcification.".

• Brand Name: BALLAST LONG SHEATH
• Common Device Name: BALLAST
• Manufacturer (Section D): BALT USA, LLC; 29 parker; irvine CA 92618
• MDR Report Key: 9098723
• Report Number: 3014162263-2019-00016
• Device Sequence Number: 11463746
• Product Code: DQY
• UDI-Device Identifier: 00818053022890
• UDI-Public: 00818053022890
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K182918
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/12/2019

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: 06/20/2024
• Device Model Number: BALLAST90
• Device Catalogue Number: N/A
• Device Lot Number: 062019D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/20/2019
• 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: Required Intervention