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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PREFACE; INTRODUCER, CATHETER
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BIOSENSE WEBSTER INC PREFACE; INTRODUCER, CATHETER Back to Search Results
Catalog Number 301803M
Device Problem Device Packaging Compromised (2916)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/08/2017
Event Type  malfunction  
Manufacturer Narrative
The device history record (dhr) review and udi are in progress.Once completed, a supplemental report will be submitted.(b)(4).
 
Event Description
It was reported that a patient underwent a procedure for atrial fibrillation with a preface sheath where the sterility of the sheath was compromised.During the procedure, when the sheath was being removed from its packaging, the crimp on the box was found to be weak.The sheath was then dropped.A new sheath was used, and the procedure was completed without patient consequence.
 
Manufacturer Narrative
On 11/10/2017, a device history record review was performed for the complaint device.As a result, the manufacturing date, expiration date and udi fields have been populated.The device history record (dhr) was reviewed, and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.On 11/13/2017, the bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Manufacturer¿s reference number: (b)(4).
 
Manufacturer Narrative
It was reported that a patient underwent a procedure for atrial fibrillation with a preface sheath where the sterility of the sheath was compromised.During the procedure, when the sheath was being removed from its packaging, the crimp on the box was found to be weak.The sheath was then dropped.A new sheath was used, and the procedure was completed without patient consequence.Product evaluation details: the returned device was visually inspected and it was found in normal condition.The original package was not returned, failure analysis was not performed due to the missing packaging.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint cannot be confirmed.Manufacturer¿s ref # (b)(4).
 
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Brand Name
PREFACE
Type of Device
INTRODUCER, CATHETER
Manufacturer (Section D)
BIOSENSE WEBSTER INC
33 technology drive
irvine CA 92618
MDR Report Key6918252
MDR Text Key89470109
Report Number9673241-2017-01146
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
PMA/PMN Number
K982740
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 09/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/29/2020
Device Catalogue Number301803M
Device Lot Number17649468
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2017
Date Manufacturer Received05/31/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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