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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

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BIOSENSE WEBSTER INC PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY Back to Search Results
Model Number D128211
Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/02/2022
Event Type  malfunction  
Manufacturer Narrative
Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection of the returned device was performed in accordance with bwi procedures.Visual inspection was performed, and one spline was found stretched and bent, the spline electrodes were observed out of their place.All units are inspected prior to leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.A manufacturing record evaluation was performed for the finished device (b)(4), and no internal action was found during the review.The issue reported by the customer was confirmed, however, no conditions were found on the device that might contributed to damage observed, this could be related to the interaction the device with the sheath, however, this cannot be conclusively determined.The instructions for use contain (ifu) the following recommendations: do not introduce the catheter into a guiding sheath with the catheter¿s distal spines folded backward toward the handle.Do not use excessive force to advance or withdraw the catheter through the guiding sheath when resistance is encountered.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Initial reporter phone: (b)(6).Explanation of codes: component code: (b)(4).Component code: (b)(4).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 an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter for which biosense webster¿s product analysis lab (pal) identified an electrode damage.It was initially reported by the customer that when pushing into sl0 sheath and trying to pull it out from the sheath, one of the spines protrudes into the sl0 side pole and cannot be pulled back.There was resistance and when pulling it out of the patient¿s body, the doctor pulled pentaray nav catheter out too strongly and the spine coating was damaged, torn.The pentaray nav high-density mapping eco catheter was exchange and the procedure was continued and completed without any problem.There was no patient consequence.The customer¿s reported issue of damaged tip and resistance with the sheath are not considered to be mdr reportable since the potential that these could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On 30-nov-2022, the bwi pal revealed that a visual inspection of the returned device spline e was stretched and bent, the electrodes on spline e were bent, with rough edges, without pu on the edges and were moved out place.These findings were reviewed and determined to be mdr reportable malfunction for the rough edges of the electrode.
 
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Brand Name
PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
Type of Device
CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
Manufacturer (Section D)
BIOSENSE WEBSTER INC
31 technology drive, suite 200
irvine CA 92618
Manufacturer (Section G)
BIOSENSE WEBSTER INC (JUAREZ)
circuito interior norte
1820parque industrial salvacar
juarez 32599
MX   32599
Manufacturer Contact
kate karberg
31 technology dr
irvine, CA 92618
3035526892
MDR Report Key16030826
MDR Text Key308473349
Report Number2029046-2022-03225
Device Sequence Number1
Product Code MTD
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K123837
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 12/21/2022
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 Model NumberD128211
Device Catalogue NumberD128211
Device Lot Number30779527L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2022
Initial Date Manufacturer Received 11/30/2022
Initial Date FDA Received12/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/12/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
PENTARAY NAV ECO 7FR, D, 2-6-2.; THMCL SMTCH SF BID, TC, D-F.
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