MAUDE Adverse Event Report: OSTIAL CORPORATION FLASH MINI OSTIAL SYSTEM; PTCA CATHETER

Model Number OCB4008BA

Device Problems Inadequacy of Device Shape and/or Size (1583); Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

Patient Problem Perforation of Vessels (2135)

Event Date 07/29/2015

Event Type  Injury  

Manufacturer Narrative

Based on the details of the case provided by the local sales representative and the hospital staff, there is no indication that the flash mini balloon did not perform as intended.The most likely potential causes identified for the vessel damage are oversizing of the balloon relative to the reference vessel diameter or incorrect positioning of the balloon too far distally within the stent; however, neither of the potential root causes can be reasonably confirmed based on the available information.While the hospital was unable to confirm the reference vessel diameter, it was noted that the diameter of the stent being dilated was 3.5mm and the diameter of the occlusion balloon used following the perforation was 2.75mm.As both are less than the 4.0mm diameter of the flash mini device being used in the procedure it is likely that the flash mini device was oversized relative to the vessel diameter.As the device from the case was discarded by the hospital and no cines from the case were available for analysis, no definitive conclusions could be drawn regarding whether or not the device was properly positioned.In addition to the case details, ostial corporation reviewed the manufacturing documentation associated with the most recently sold lots of 4.0x8mm flash mini devices.No issues were noted that would have contributed to the reported incident.The instructions for use for the product were also reviewed and it was verified that perforation is listed as a potential complication associated with the procedure.User facility discarded device.

Event Description

A 3.5 x 15mm medtronic resolute integrity stent was deployed at the ostium of the right coronary artery (rca).Following use of a 4.0x8mm flash mini ostial system within the stent, a perforation was noted on the distal end of the stent.A 2.75x20mm medtronic euphora balloon was used to occlude the perforated area.The patient was transferred for immediate emergent bypass.Follow up with the hospital staff indicated that the patient had recovered from the surgery and no further complications were noted.

• Brand Name: FLASH MINI OSTIAL SYSTEM
• Type of Device: PTCA CATHETER
• Manufacturer (Section D): OSTIAL CORPORATION; 1221 innsbruck drive; sunnyvale CA 94089 1317
• Manufacturer (Section G): OSTIAL CORPORATION; 1221 innsbruck drive; sunnyvale CA 94089 1317
• Manufacturer Contact: jake wolenberg ; 1221 innsbruck drive; sunnyvale, CA 94089-1317 ; 4085411006
• MDR Report Key: 5040417
• MDR Text Key: 24516985
• Report Number: 3008700817-2015-00004
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131450
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Report Date: 08/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OCB4008BA
• Device Catalogue Number: OCB4008BA
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 59 YR