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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); Sharp Edges (4013)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/03/2021
Event Type  malfunction  
Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 04-sep-2021.The device evaluation was completed on (b)(6) 2021.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection, and outer diameter (od) test of the returned product.Visual analysis of the returned sample revealed electrodes lifted -crushed on spines, this condition could be related to handling of the device during the procedure; however, this cannot be conclusively determined.The od test failed due this condition.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device 30534287l number, and no internal action was found during the review.Instructions for use states the following recommendation to avoid resistance or friction issues: -the pentaray¿ nav eco catheter is recommended for use with an 8f guiding sheath.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).
 
Event Description
It was reported that a patient underwent an atrial flutter (afl) procedure with a pentaray nav high-density mapping eco catheter and the biosense webster, inc.Product analysis lab observed electrodes lifted crushed on spine issue.Initially it was reported that the pentaray nav high-density mapping eco catheter would not pass through the vizigo sheath.The smarttouch catheter passed through with no issues.There was no patient consequence reported.The issue with the pentaray nav high-density mapping eco catheter was assessed as not mdr reportable for an impeded device issue.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6) 2021 electrodes lifted crushed on spine were observed.The electrodes lifted crushed on spine was assessed as mdr reportable.The awareness date for this reportable lab finding was (b)(6) 2021.
 
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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
MDR Report Key12637117
MDR Text Key281991674
Report Number2029046-2021-01747
Device Sequence Number1
Product Code MTD
UDI-Device Identifier10846835012255
UDI-Public10846835012255
Combination Product (y/n)N
PMA/PMN Number
K123837
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial
Report Date 10/14/2021
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 Date03/10/2024
Device Model NumberD128211
Device Catalogue NumberD128211
Device Lot Number30534287L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/04/2021
Initial Date Manufacturer Received 09/30/2021
Initial Date FDA Received10/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
8.5F SHEATH WITH CURVE VIZ MDC; PENTARAY NAV ECO 7FR, D, 2-6-2; SMARTTOUCH CATHETER
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