MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NGEN PUMP, EU CONFIGURATION

Catalog Number D139701

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Air Embolism (1697); Ischemic Heart Disease (2493)

Event Date 08/31/2022

Event Type  Injury  

Event Description

It was reported that a female patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter and a ngen pump, eu configuration and the patient suffered an air embolism and st segment elevation.It was reported by the customer to the biosense webster inc (bwi) representative that they tried to insert the pentaray nav high-density mapping eco catheter into a oscor's destino reach steerable sheath, but the catheter could not be advanced.After several attempts, the customer decided to replace the sheath.The same problem occurred with the new sheath.After the second attempt, the patient developed st elevations which, according to the client, were probably caused by air embolization.A second examiner was then able to insert the catheter.The procedure was successfully completed, the st elevations were fully reversible, and the patient did not retain any permanent damage.The reason for this is probably that the first examiner inserted the insertion sleeve of the pentaray nav high-density mapping eco catheter into the sheath.The second examiner then asked the bwi representative to send him the instructions for use (ifu) for the pentaray nav high-density mapping eco catheter.They complied with this request.The doctor is of the opinion that the insertion of the catheter is not sufficiently documented in the ifu and now wants to hand the catheter over to the bfarm.The surgery was not delayed due to the reported event.The procedure was successfully completed.No fragments were generated.The physician¿s opinion on the cause of this adverse event is bwi product malfunction; the user feels that the catheter¿s ifu does not provide the necessary information on the procedure for inserting the device.Intervention provided was pulmonary vein isolation (pvi).The patient outcome of the adverse event is fully recovered with no residual effects.The patient did not require extended hospitalization because of the adverse event.

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2022-02410 for product code d128207 (pentaray nav high-density mapping eco catheter).(2) mfr # for product code d139701 (ngen pump, eu configuration).

Manufacturer Narrative

It was reported that a female patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter and a ngen pump, eu configuration and the patient suffered an air embolism and st segment elevation.It was reported by the customer to the biosense webster inc (bwi) representative that they tried to insert the pentaray nav high-density mapping eco catheter into a oscor's destino reach steerable sheath, but the catheter could not be advanced.After several attempts, the customer decided to replace the sheath.The same problem occurred with the new sheath.After the second attempt, the patient developed st elevations which, according to the client, were probably caused by air embolization.A second examiner was then able to insert the catheter.The procedure was successfully completed, the st elevations were fully reversible, and the patient did not retain any permanent damage.Device investigation details: the device investigation has been completed which included a device history record evaluation.A device history record evaluation performed for the finished device number (101920-105) identified no internal actions related to the reported complaint condition.Repair follow-up was performed as the device was not shipped for service or repair.Clinical personnel in charge at the facility confirmed that servicing for the pump is not required and service for the unit was declined.As such, the reported complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: NGEN PUMP, EU CONFIGURATION
• Type of Device: NGEN PUMP
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER, INC.; 560 cottonwood drive; milpitas CA
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15548455
• MDR Text Key: 301239436
• Report Number: 2029046-2022-02411
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P990071/S037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D139701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: OSCOR'S DESTINO REACH STEERABLE SHEATH; PENTARAY NAV ECO 7FR, F, 4-4-4
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Female