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

Model Number OCB4508BA

Device Problems Improper or Incorrect Procedure or Method (2017); Activation, Positioning or Separation Problem (2906); Device Handling Problem (3265)

Patient Problems Death (1802); Vascular Dissection (3160)

Event Date 09/14/2017

Event Type  Death  

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 likely root cause for this incident was oversizing of the balloon diameter relative to the diameter of the target vessel/stent.The balloon to vessel ratio in this case, 1.5 (4.5mm / 3.0mm), is known to significantly increase the risk for vessel dissection.It is also noted that the calcification of the patient's rca further increased the risk of dissection in this procedure.In addition to the case details, ostial corporation reviewed the manufacturing documentation and lot release testing associated with the device lot used during the procedure.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 vessel dissection is listed as a potential complication associated with the procedure and that the user is clearly instructed to appropriately match the balloon diameter to the diameter of the vessel/stent being treated.

Event Description

The following information regarding the reported event was obtained from the hospital and local sales representatives: the patient was admitted to the er and then taken to the cath lab for treatment of stemi.The physician deployed a 3.0mm diameter stent in a calcified chronic total occlusion of the rca and then requested a flash device for use in post-dilation of the stent.The cath lab did not have any 3.0mm diameter flash devices at the time, only a 4.5mm diameter flash device was available.The physician decided to use the higher diameter 4.5mm diameter flash device to post dilate the 3.0mm stent.Following inflation of the flash device, a dissection occurred and the vessel shut down.Cpr was immediately started; however, the patient subsequently expired.

• 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: 6962212
• MDR Text Key: 89740616
• Report Number: 3008700817-2017-00005
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: M917OCB4508BA0
• UDI-Public: M917OCB4508BA0
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2017
• Device Model Number: OCB4508BA
• Device Catalogue Number: OCB4508BA
• Device Lot Number: 160317-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2016
• 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
• Treatment: STENT (UNKNOWN MAKE/MODEL)
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 89 YR