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

Model Number OCB3008BA

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

Patient Problem Perforation of Vessels (2135)

Event Date 05/11/2015

Event Type  Injury  

Event Description

Per the sales representative who interviewed the supervising physician following the case: the rca had a 99% ostial blockage.The doctor used a 2.75 mm x 16 mm stent and post dilatation balloon.A 3.0 mm x 8 mm flash was subsequently used.The distal balloon was inflated without issues.When the proximal balloon was inflated, it expanded distal to the stent, damaging the vessel.At least one covered stent was placed to address the damage.The pt was stable following placement of the covered stent.

Manufacturer Narrative

The device used in the procedure was returned to ostial corp for eval.A two page summary of the eval has been attached.No issues were found with the performance of the returned device, though the distal portion of the proximal balloon had clearly been deformed by overexpansion during use.Per the results of the eval, it was found that the most likely root cause of the incident was grossly incorrect positioning of the device prior to inflation.In addition to the case details, ostial corp review the mfg documentation 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 prod were also reviewed and it was verified that vessel perforation is listed as a potential complication associated with the procedure and that the user is clearly instructed on how the device should be positioned during use.See scanned pages.

• Brand Name: FLASH MINI OSTIAL SYSTEM
• Type of Device: PTCA CATHETER
• Manufacturer (Section D): OSTIAL CORP.; sunnyvale CA
• Manufacturer Contact: jake wolenberg ; 1221 innsbruck dr; sunnyvale, CA 94089-1317 ; 4085411006
• MDR Report Key: 4843692
• MDR Text Key: 22249120
• Report Number: 3008700817-2015-00003
• 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: Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2015
• Device Model Number: OCB3008BA
• Device Catalogue Number: OCB3009BA
• Device Lot Number: 040214-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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: 2.75MM X 16MM STENT (UNK MAKE); POST DILATATION BALLOON (UNK MAKE)
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 68