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

Model Number	OCB4508BA
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Activation, Positioning or Separation Problem (2906); Device Handling Problem (3265)
Health Effect - Clinical Codes	Death (1802); Vascular Dissection (3160)
Date of Event	09/14/2017
Type of Reportable Event	Death
Additional 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 or Problem 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
• Common Device Name: PTCA CATHETER
• Manufacturer (Section D): OSTIAL CORPORATION; 1221 innsbruck drive; sunnyvale CA 94089 1317
• MDR Report Key: 6962212
• Report Number: 3008700817-2017-00005
• Device Sequence Number: 13738714
• Product Code: LOX
• UDI-Device Identifier: M917OCB4508BA0
• UDI-Public: M917OCB4508BA0
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K131450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/18/2017

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: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STENT (UNKNOWN MAKE/MODEL)
• Outcome Attributed to Adverse Event: Death; Life Threatening
• Patient Age: 89 YR