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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THMCL SMTCH SF BID, TC, D-F; CARDIAC ABLATION PERCUTANEOUS CATHETER
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BIOSENSE WEBSTER INC THMCL SMTCH SF BID, TC, D-F; CARDIAC ABLATION PERCUTANEOUS CATHETER Back to Search Results
Model Number D134805
Device Problem Material Perforation (2205)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/10/2019
Event Type  malfunction  
Manufacturer Narrative
The investigational analysis completed 1/7/2019.The device was visually inspected and a silver piece of material was found on the distal tip.During the second visual inspection, ring #1 was received inside a plastic bag.A silver piece found on the distal tip and ring #1 was observed squashed and lifted.Electrical testing was performed on the catheter.The catheter failed the test.The electrode was damaged and the thermocouple values were found out of specifications.A failure analysis was performed and it was found that there is an electrical failure on the tip area creating the temperature issue.The catheter outer diameter was measured and it was found within specification.A manufacturing record evaluation was performed and no internal actions were identified.The customer complaint was confirmed.The temperature issue does not represent any patient safety impact since the device is unable to deliver rf energy to ablate.The root cause of the electrode damaged cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures.It could be related to the handling of the device during the shipment.However, this cannot be conclusively determined.(b)(4).
 
Event Description
It was reported that a patient underwent an ablation procedure for atrial fibrillation with a thermocool® smart touch® sf bi-directional navigation catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found ring#1 lifted.Initially it was reported the ablation catheters were unable to go into the sheath.The case was completed without the sheath.It was also reported that the generator displayed an invalid temperature reading.The cable was replaced with no resolution.When the catheter was replaced, the issue resolved.The catheter never displayed a temperature on the smart ablate.Initially the cable was replaced to make sure it wasn¿t just a cable issue.We were unable to come on ablation because there was no temperature listed.Replacing the cable did not resolve our problem so the catheter was replaced and had no further issues.No adverse patient consequences were reported.The observed obstructed sheath and no temperature reading issues has been assessed as not mdr reportable.On 12/16/2019, the bwi pal received the device for evaluation.Upon initial inspection, a silver piece of material was found on the distal tip.During a second visual inspection, ring 1 was observed squashed and lifted.The observed silver piece lifted ring has been assessed as an mdr reportable malfunction as the device integrity was compromised.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The awareness date has been reset to 12/16/2019.
 
Manufacturer Narrative
It was reported that a patient underwent an ablation procedure for atrial fibrillation with a thermocool® smart touch® sf bi-directional navigation catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found ring#1 lifted.In the initial, it was reported in the investigational analysis, that the root cause of the electrode damaged could be related to the ¿handling of the device during the shipment¿.After further review of the investigation, it was discovered that the root cause of the electrode damage could be related to the handling of the device ¿during the procedure¿.The 8.5f sheath with curve viz smc has been added to concomitants, as it was omitted in error from the initial.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).
 
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Brand Name
THMCL SMTCH SF BID, TC, D-F
Type of Device
CARDIAC ABLATION PERCUTANEOUS CATHETER
Manufacturer (Section D)
BIOSENSE WEBSTER INC
33 technology drive
irvine CA 92618
MDR Report Key9585911
MDR Text Key200066302
Report Number2029046-2020-00080
Device Sequence Number1
Product Code LPB
UDI-Device Identifier10846835010183
UDI-Public10846835010183
Combination Product (y/n)N
PMA/PMN Number
P030031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 12/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/28/2020
Device Model NumberD134805
Device Catalogue NumberD134805
Device Lot Number30258521M
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2019
Date Manufacturer Received02/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
8.5F SHEATH WITH CURVE VIZ SMC
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