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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. LASSO NAV ECO VARIABLE CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
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BIOSENSE WEBSTER INC. LASSO NAV ECO VARIABLE CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING Back to Search Results
Model Number D134301
Device Problem Failure to Unfold or Unwrap (1669)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/07/2020
Event Type  malfunction  
Manufacturer Narrative
A manufacturing record evaluation was performed for the finished device (b)(4) number, and no internal actions related to the reported complaint condition were identified.Initial reporter phone (b)(6).Initial reporter fax: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
 
Event Description
It was reported that a patient underwent cardiac ablation procedure with a lasso® nav eco variable catheter where a knotted loop issue occurred.During mapping phase, while maneuvering, physician had difficulty expanding the loop.Then noticed the knot.Lasso® nav eco variable catheter got tangled and while withdrawing into steerable sheath to straighten, tangling got pushed and resulted in a knot on the catheters loop.Catheter was then withdrawn again inside the steerable sheath, and retrieved outside of the patient body without any further consequences.There was no detachment of any component.The issue did not result in exposure of any internal catheter components or sharp edges.No surgical intervention required for the catheter withdrawal.No excessive manipulation during the catheter withdrawal.Sheath with lasso® nav eco variable catheter inside was retrieved with usual manipulation.
 
Manufacturer Narrative
On 10/14/2020, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.(b)(4).
 
Manufacturer Narrative
It was reported that a patient underwent cardiac ablation procedure with a lasso® nav eco variable catheter where a knotted loop issue occurred.During mapping phase, while maneuvering, physician had difficulty expanding the loop.Then noticed the knot.Lasso® nav eco variable catheter got tangled and while withdrawing into steerable sheath to straighten, tangling got pushed and resulted in a knot on the catheters loop.Catheter was then withdrawn again inside the steerable sheath and retrieved outside of the patient body without any further consequences.Device evaluation details: the device evaluation has been completed.Upon receipt, the catheter was inspected, and it was found with a knott on the tip.During manufacturing process all the catheters are inspected for visual damages before packaging.On-line inspections are in place to prevent this type of damage from leaving the facility.A manufacturing record evaluation was performed for the finished device and no internal action related to the complaint was found during the review.The customer complaint was confirmed.The root cause of the knott 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 procedure, however, this cannot be conclusively determined.Additionally, the customer had also provided photos to aid in the investigation.According to pictures provided by customer, tip was observed knotted.Based on the picture received, the customer¿s complaint was confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.#: (b)(4).
 
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Brand Name
LASSO NAV ECO VARIABLE CATHETER
Type of Device
CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
Manufacturer (Section D)
BIOSENSE WEBSTER INC.
33 technology drive
irvine CA 92618
MDR Report Key10633065
MDR Text Key209983172
Report Number2029046-2020-01426
Device Sequence Number1
Product Code DRF
UDI-Device Identifier10846835009637
UDI-Public10846835009637
Combination Product (y/n)N
PMA/PMN Number
K113213
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 09/07/2020
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 Date11/11/2022
Device Model NumberD134301
Device Catalogue NumberD134301
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/07/2020
Initial Date FDA Received10/06/2020
Supplement Dates Manufacturer Received10/14/2020
11/17/2020
Supplement Dates FDA Received11/05/2020
12/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNKNOWN STEERABLE SHEATH.; UNKNOWN STEERABLE SHEATH
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