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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC T; SIMILAR DEVICE D133601, PMA # P030031/S053
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BIOSENSE WEBSTER INC T; SIMILAR DEVICE D133601, PMA # P030031/S053 Back to Search Results
Catalog Number D133604IL
Device Problems High Readings (2459); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/09/2017
Event Type  malfunction  
Manufacturer Narrative
Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.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.(b)(4).
 
Event Description
It was reported that a patient underwent an atrial fibrillation procedure with a thermocool smarttouch unidirectional catheter and foreign material was discovered on the catheter tip.During the procedure, the force value was too high and displayed approximately 80g.The catheter was withdrawn from the patient and the physician discovered damage to the catheter tip.After further assessment, there was actually foreign material on the tip of the catheter.There were no wires exposed and no difficulty removing the catheter.The integrity of the catheter was not compromised and there was no tip detachment.The catheter was changed and the procedure was completed with no patient consequence.The high force issue is not mdr reportable because the potential that it could cause or contribute to a death or serious injury is low.However, if foreign material that is found adhered to the catheter within the usable length during or after the procedure, there is a potential risk to the patient.
 
Manufacturer Narrative
The bwi failure analysis lab received the device for evaluation on 11/27/2017.The analysis has begun but is not completed at this time.Whitish material was found outside near the pebax of the catheter.This finding coincides with the reported event.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 an atrial fibrillation procedure with a thermocool smarttouch unidirectional catheter and foreign material was discovered on the catheter tip.In addition, during the procedure, the force value was too high and displayed approximately 80g.The returned device was visually inspected and whitish material was found outside near the pebax of the catheter.Then, the catheter was evaluated for carto 3 and it was recognized by the system, no error messages were displayed and the catheter was properly visualized.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.The catheter was evaluated for screening test and the catheter passed.The force feature was working properly.Finally, the force sensor values were found within specifications.Then, the catheter outer diameter was measured and it was found within specifications.Per material observed on the catheter tip, a fourier transform infrared spectroscopy (ft-ir) was performed and the results showed that foreign material has a biological-base material presumably human tissue.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.During manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of damage from leaving the facility.The customer complaint cannot be confirmed.The foreign material on the catheter tip does not appear to be caused by any internal bwi processes since the device was manufactured in accordance with documented specification and procedures, it could be related to the handling of the catheter during the procedure.(b)(4).
 
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Brand Name
T
Type of Device
SIMILAR DEVICE D133601, PMA # P030031/S053
Manufacturer (Section D)
BIOSENSE WEBSTER INC
33 technology drive
irvine CA 92618
MDR Report Key6994889
MDR Text Key91471106
Report Number2029046-2017-01092
Device Sequence Number1
Product Code LPB
Combination Product (y/n)N
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 10/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2018
Device Catalogue NumberD133604IL
Device Lot Number17701465M
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2017
Initial Date Manufacturer Received 10/11/2017
Initial Date FDA Received11/01/2017
Supplement Dates Manufacturer Received10/11/2017
10/11/2017
Supplement Dates FDA Received12/12/2017
01/17/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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