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

Catalog Number D139402

Device Problems Insufficient Cooling (1130); Material Puncture/Hole (1504)

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

Event Date 10/22/2021

Event Type  malfunction  

Event Description

It was reported that a (b)(6) patient underwent a persistent atrial fibrillation (afib) procedure with a qdot-micro, uni-directional, f curve, c3, split handle and the biosense webster, inc.Product analysis observed a hole on the pebax.Initially it was reported that the temperature slope was high during ablation.There was no patient consequence reported.Additional information was received on the event.The temperature cut-off was not exceeded.During that procedure, they did ablate with the interested catheter.The issue appeared before the ablation.The generator parameters selected: qmode 50w 55c ¿ qmode+ 85w 65c.The high temperature issue was assessed as not mdr reportable.Since the user-defined cut-off was not exceeded the potential that it could cause or contribute to a death, 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) 2022 observed reddish material and a hole on the pebax of the qdot device.The hole on the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding was (b)(6) 2022.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 27-jan-2022.The device evaluation was completed on (b)(6) 2022.The device was returned to biosense webster for evaluation.Bwi conducted a visual inspection and functional testings of the returned device.Visual analysis revealed reddish material and a hole on the pebax of the qdot device.All units are inspected prior to leaving the facility to avoid this type of damage.With the available information, it can be concluded that the issue occurred outside the manufacturing environment.Generator testing was performed, in accordance with bwi procedures.The device temperature was working correctly and within specifications.Then, the flow test was performed and was found within specifications.The temperature issue reported by the customer was unable to be replicated; however, the foreign material inside the pebax could be related to the issue.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 30432172l number, and no internal actions related to the complaint were found during the review.The instructions for use contain the following recommendations that should be considered: monitor the catheter tip temperature throughout the procedure to ensure adequate irrigation.The ¿suspected medical device¿ reported in this report is not marketed in usa or approved by the fda.However, it is being reported as biosense webster considers this as a similar device to thermocool® smart touch® sf uni-directional navigation catheter approved under p030031/s078.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 30-mar-2022, the investigation was reopened to perform additional investigation which resulted in the following change.The device was returned to biosense webster (bwi) for evaluation.Bwi conducted a visual inspection, functional tests, and a sem (scanning electron microscopy) analysis.Visual analysis revealed reddish material and a hole on the pebax of the qdot device.Generator testing was performed following bwi procedures.The device temperature was working correctly and within specifications.Then, the flow test was performed and was found within specifications.A sem was performed due to the condition observed.Mechanical damage occurred from the outside to the inside.The object that could cause the damage is unknown.All units are inspected prior to leaving the facility to avoid this type of damage.With the available information, it can be concluded that the issue occurred outside the manufacturing environment.The temperature issue reported by the customer was unable to be replicated.However, the foreign material inside the pebax can be related to the temperature failure experienced by the customer.A manufacturing record evaluation was performed for the finished device number, and no internal actions related to the reported complaint condition were identified.All devices are manufactured, inspected, and released to approved specifications as part of bwi's quality process.The instructions for use contain the following recommendations that should be considered: monitor the catheter tip temperature throughout the procedure to ensure adequate irrigation.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, F 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: 13712904
• MDR Text Key: 290469754
• Report Number: 2029046-2022-00496
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 04/21/2022

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 Expiration Date: 05/20/2022
• Device Catalogue Number: D139402
• Device Lot Number: 30432172L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/13/2022
• Initial Date FDA Received: 03/09/2022
• Supplement Dates Manufacturer Received: 03/30/2022
• Supplement Dates FDA Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2021
• 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: UNK_NGEN RF GENERATOR.