MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT-MICRO, UNI-DIRECTIONAL, J CURVE, C3, SPLIT HANDLE; SIMILAR DEVICE D134701, PMA # P030031/S078

Catalog Number D139403

Device Problems Material Puncture/Hole (1504); Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).The bwi product analysis lab received the device for evaluation on 05-jan-2022.The device evaluation was completed on 07-jan-2022.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed a hole in the pebax of the qdot microcatheter.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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.The instructions for use contain the following warning stated in the carto 3 system manual: before use, check irrigation ports are patent by infusing heparinized normal saline through the catheter and tubing.Also, do not continue the use of the catheter if is not functioning properly or present physical damage.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.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

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a qdot-micro, uni-directional, j curve, c3, split handle, and the biosense webster, inc.Product analysis lab observed a hole on the pebax.Initially, during the procedure, when removing the catheter from the patient to insert a sheath, they found traces of blood accumulated between the tip of the catheter and the body of the catheter on the inside.They tried to wash with saline solution through the irrigation channel but the blood remained in the same place.They tried to clean it on the outside but it was not on the outside.They finally decided to exchange and discard the catheter.The procedure was completed successfully.The surgery was delayed due to the reported event by 5 minutes.There were no patient consequences reported.The agilis long curve 8.5f sheath was used.There was no difficulty experienced while maneuvering the catheter or during the withdrawal.The catheter pebax was apparently not physically damaged.The event was assessed as not mdr reportable for foreign material inside the pebax with no external damage.Foreign material was found underneath the pebax.However, there was no damage to the pebax integrity that could cause the foreign material to travel into the blood circulation.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 07-jan-2022 there was reddish material found inside the pebax and a hole was observed.The hole on the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding was 07-jan-2022.

Manufacturer Narrative

The product has been returned for analysis and details already reported in a previous medwatch report, however, a picture of the complaint device was provided by the customer on(b)(6)-2022.Evaluation of this picture is still in progress.The 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 reference number: (b)(4).

Manufacturer Narrative

H6.Investigation findings code of ¿appropriate term/code not available¿ represents photo/video analysis.It was reported that a patient underwent an atrial fibrillation (afib) procedure with a qdot-micro, uni-directional, j curve, c3, split handle.During the procedure, when removing the catheter from the patient to insert a sheath, they found traces of blood accumulated between the tip of the catheter and the body of the catheter on the inside.They tried to wash with saline solution through the irrigation channel but the blood remained in the same place.They tried to clean it on the outside but it was not on the outside.They finally decided to exchange and discard the catheter.The procedure was completed successfully.There were no patient consequences reported.The agilis long curve 8.5f sheath was used.There was no difficulty experienced while maneuvering the catheter or during the withdrawal.The catheter pebax was apparently not physically damaged.The photograph investigation was completed on 07-jan-2022.According to the pictures provided by the customer, there was observed reddish material inside the pebax.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The instructions for use contain the following warning stated in the carto 3 system manual: before use, check irrigation ports are patent by infusing heparinized normal saline through the catheter and tubing.Also, do not continue the use of the catheter if is not functioning properly or present physical damage.Customer complaint was confirmed based on the picture received.The physical product investigation was reported under the 3500a initial.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: QDOT-MICRO, UNI-DIRECTIONAL, J CURVE, C3, SPLIT HANDLE
• Type of Device: SIMILAR DEVICE D134701, PMA # P030031/S078
• 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 ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13310800
• MDR Text Key: 289326173
• Report Number: 2029046-2022-00130
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2022

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 Expiration Date: 12/03/2021
• Device Catalogue Number: D139403
• Device Lot Number: 30432183L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/07/2022
• Initial Date FDA Received: 01/20/2022
• Supplement Dates Manufacturer Received: 01/21/2022; 01/31/2022
• Supplement Dates FDA Received: 01/24/2022; 02/02/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NON BWI-AGILIS LONG CURVE 8.5F SHEATH.; UNKNOWN BRAND CATHETER.