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U.S. Department of Health and Human Services

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

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OSTIAL CORPORATION FLASH MINI OSTIAL SYSTEM PTCA CATHETER Back to Search Results
Model Number OCB4508BA
Device Problems Improper or Incorrect Procedure or Method (2017); Activation, Positioning or SeparationProblem (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.
 
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Brand NameFLASH MINI OSTIAL SYSTEM
Type of DevicePTCA 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 Key6962212
MDR Text Key89740616
Report Number3008700817-2017-00005
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131450
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
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 Received10/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2017
Device Model NumberOCB4508BA
Device Catalogue NumberOCB4508BA
Device Lot Number160317-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/30/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/19/2017 Patient Sequence Number: 1
Treatment
STENT (UNKNOWN MAKE/MODEL)
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