MAUDE Adverse Event Report: BIOSENSE WEBSTER INC DECANAV ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number R7F282CT

Device Problems Material Twisted/Bent (2981); Patient Device Interaction Problem (4001)

Patient Problem Perforation of Vessels (2135)

Event Date 10/21/2022

Event Type  Injury  

Manufacturer Narrative

The bwi product analysis lab received the 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.However, a photo was received an analyzed.Device investigation details: a picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, the shaft of the catheter was observed with a kinked condition, this condition is related to the customer experience at the procedure time.A manufacturing record evaluation was performed for the finished device number 30904773m, and no internal actions related to the reported complaint were identified.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).

Event Description

It was reported that a patient (male in their 70s) underwent an atrial fibrillation (afib) ablation procedure with a decanav electrophysiology catheter.The patient suffered vessel perforation.It was reported that with the insertion of the decanav catheter at the beginning of an a-fib procedure, a venous perforation in the groin area occurred.The injury was confirmed with staining on xray and contrast.The bwi representative reported that they had not heparinized the patient yet and that after the decanav catheter was removed from the body, the decanav catheter was discovered to be kinked.They replaced the decanav catheter.They performed a 20-minute evaluation of the patient, heparinized the patient, continued the procedure and went transeptal.There was no medical intervention provided and that the perforation sealed itself off.The procedure was completed.The patient was reported to be in stable condition.The kink did not result in the wires being exposed or in any lifted or sharp rings.There was no resistance or difficulty during insertion, but the physician had difficulty removing, had to manipulate the catheter for it to ¿break free¿ of whatever it was caught on or in.Picture available.The catheter was f curve unidirectional.No further shaping performed by md.Sheath was a terumo 7 fr 10cm.Physician¿s opinion on the cause of this adverse event was the patient anatomy.Outcome of the adverse event was improved by end of case.Proceeded with case.Patient did not require extended hospitalization because of the adverse event.Relevant tests/laboratory data- contrast groin vein gram performed in procedure after occurrence and at end of case.Other relevant history- none.Bent shaft is not 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 18-nov-2022, the product investigation was completed.It was reported that a patient (male in their 70s) underwent an atrial fibrillation (afib) ablation procedure with a decanav electrophysiology catheter.The patient suffered vessel perforation.Device evaluation details: visual analysis revealed the shaft was kinked, no metal exposed.The probable root cause of this damage could be related to the usage and handling of the device outside the bwi manufacturing facilities.Per the event, several tests were performed.The magnetic, and electrical features were tested, and no issues were observed.In addition, the product was deflecting correctly.A manufacturing record evaluation was performed for the finished device 30904773m number, and no internal action was found during the review.The bent issue reported by the customer was confirmed.The root cause of the adverse event remains unknown.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.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 20-dec-2022, the photo analysis was completed.Device investigation details: a picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, the shaft of the catheter was observed with a kinked condition, this condition is related to the customer experience at the procedure time.A manufacturing record evaluation was performed for the finished device number (b)(6), and no internal actions related to the reported complaint 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).

• Brand Name: DECANAV ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 15817143
• MDR Text Key: 303847334
• Report Number: 2029046-2022-02854
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835008807
• UDI-Public: 10846835008807
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2023
• Device Model Number: R7F282CT
• Device Catalogue Number: R7F282CT
• Device Lot Number: 30904773M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2022
• Initial Date FDA Received: 11/17/2022
• Supplement Dates Manufacturer Received: 11/18/2022; 12/20/2022
• Supplement Dates FDA Received: 12/16/2022; 01/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2022
• 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
• Treatment: TERUMO 7 FR 10CM.
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male