• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - LARGE INTRODUCER, CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - LARGE INTRODUCER, CATHETER Back to Search Results
Model Number D138503
Device Problems Fracture (1260); Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/22/2021
Event Type  malfunction  
Manufacturer Narrative
The product investigation was completed. Device evaluation details: visual analysis of the returned sample revealed that no damage or anomalies were observed on the vizigo sheath. The device was visually inspected, several damages were found in the shaft of the dilator and sheath device. Additionally, the internal puller wire was found broken and outside in the distal tip area. Functional testing was performed accordingly with bwi procedures. The dilator was introduced into the vizigo sheath and obstruction was observed due the puller wire damage observed on the tip of the sheath; and deflection test could not be performed. Further investigation was performed with freudenberg medical and concluded that this failure mode of broken pull wire near the distal tip of the device has never been seen in freudenberg medical's process. Inspections of the complaint device revealed that something indeed punctured through the main liner and the pull wire lumen, and likely became entangled or broke/cut the pull wire. This complaint is not deemed freudenberg medical manufacturing attributable. The obstruction reported by the customer it could be related to the puller wire condition. The device history record (dhr) for the lot number 00001631 has been received and no internal action related to the complaint was found during the review. It should be noted that product failure is multifactorial. The instructions for use contain the following warning stated in the instructions for use (ifu): "do not attempt to use a guidewire larger than 0. 032 inches in diameter with the dilator provided. Doing so may compromise the structural integrity of the dilator or the guidewire and/or lead to the failure of the sheath or guidewire being used. " if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda. Manufacturer's reference number: (b)(4).
 
Event Description
A patient underwent an ablation procedure with a carto vizigo¿ 8. 5f bi-directional guiding sheath - large for which biosense webster¿s product analysis lab identified several damages along the shaft device and dilator (kinks). In addition, the puller wire was observed pulled out in the tip area of the sheath. The findings were identified on (b)(6) 2022. It was reported that during the procedure, there was a lot of resistance when inserting the dilator into the vizigo sheath. The medical team was unable to advance the dilator when it got to approximately 1/3rd of the way into the sheath. The team applied so much pressure trying to insert the dilator that it got kinked. When the vizigo sheath was replaced, the issue resolved. There were no patient consequences reported. Sheath obstruction is not mdr-reportable. Broken tip is mdr-reportable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - LARGE
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
BIOSENSE WEBSTER INC
31 technology drive, suite 200
irvine CA 92618
Manufacturer (Section G)
BIOSENSE WEBSTER INC (IRVINE)
33 technology drive
irvine CA 92618
Manufacturer Contact
gabriel alfageme
31 technology dr
irvine, CA 92618
9497898687
MDR Report Key13627361
MDR Text Key286654243
Report Number2029046-2022-00412
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10846835016260
UDI-Public10846835016260
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170997
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2022
Device Model NumberD138503
Device Catalogue NumberD138503
Device Lot Number00001631
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2021
Date Manufacturer Received02/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/28/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-