MAUDE Adverse Event Report: OSTIAL CORPORATION FLASH; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number OCB5014BA

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Rupture (2208)

Event Date 02/01/2017

Event Type  Death  

Event Description

Physician reported the balloon had opened in the opposite direction, thereby causing a rupture of the left anterior descending (lad) vessel.The pt expired within 24 hours post procedure.

• Brand Name: FLASH
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): OSTIAL CORPORATION; 1221 innsbruck dr.; sunnyvale CA 94089
• MDR Report Key: 6328620
• MDR Text Key: 67347597
• Report Number: 6328620
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2018
• Device Model Number: OCB5014BA
• Device Lot Number: 160627-03
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 79 YR
• Patient Weight: 61