MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OCTARAY, PERSEID, 48P, 2-2-2-2-2, D-CURVE; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D160901

Device Problems Contamination (1120); Entrapment of Device (1212); Patient Device Interaction Problem (4001)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 02/01/2023

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).The bwi product analysis lab received photographs of the complaint device for evaluation.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc-(b)(4).

Event Description

It was reported that a patient underwent a premature ventricular contraction with an octaray, perseid, 48p, 2-2-2-2-2, d-curve.The patient suffered a soft tissue injury.It was reported that the octaray got stuck and was not able to be removed.Timing when complaints occurred was at the time of right ventricular outflow tract (rvot) insertion.The octaray was pulled strongly and removed.There was no effusion after the procedure.There was no problem with the spine of the octaray, but something like meat pieces were attached.The patient's condition is recovering.As this is a rare event, the physician wants to share it within the company.There were no abnormalities observed prior to and during use of the product.The adverse event occurred on (b)(6) 2023.The adverse event was discovered during use of biosense webster products.Outcome of the adverse event was fully recovered (no residual effects.Biological material is not mdr-reportable.Medical device entrapment with excessive manipulation required is mdr-reportable.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

On 28-apr-2023, a product investigation was completed based on the received photograph and video of the complaint device.It was reported that a patient underwent a premature ventricular contraction with an octaray, perseid, 48p, 2-2-2-2-2, d-curve.The patient suffered a soft tissue injury.It was reported that the octaray got stuck and was not able to be removed.Timing when complaints occurred was at the time of right ventricular outflow tract (rvot) insertion.The octaray was pulled strongly and removed.There was no effusion after the procedure.There was no problem with the spine of the octaray, but something like meat pieces were attached.The patient's condition is recovering.As this is a rare event, the physician wants to share it within the company.Device investigation details: the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A pictures and video were received for evaluation following biosense webster's procedures.According to pictures and video provided by the customer, human tissue was observed attached to the tip of the octaray catheter.According to the video provided by the customer, it looks like that the octaray catheter was entangled with itself, however this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device 30906325l number, and no internal action related to the complaint was found during the review.The customer complaint was confirmed based on the picture received.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.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

On 27-mar-2023, bwi received additional information regarding the event.The adverse event occurred on 1-feb-2023.The adverse event was discovered during use of biosense webster products.Outcome of the adverse event was fully recovered (no residual effects).Physician¿s opinion on the cause of this adverse event was because the cause was derived from patient¿s anatomy, the cause was not recognized as being derived from the bw product.Patient did not require extended hospitalization because of the adverse event.Relevant tests/laboratory data ---nothing in particular.Other relevant history --- nothing in particular.Smart ablate was used.Sheath used was abbott.Swartz.Sl0 8.5f.The physician felt resistance while retracting the catheter from the sheath.The insertion tool was 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).

• Brand Name: OCTARAY, PERSEID, 48P, 2-2-2-2-2, D-CURVE
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• 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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16457184
• MDR Text Key: 310406883
• Report Number: 2029046-2023-00402
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835021141
• UDI-Public: 10846835021141
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K193237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2023
• Device Model Number: D160901
• Device Catalogue Number: D160901
• Device Lot Number: 30906325L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2022
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 112 KG