MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVI-STAR THERMO-COOL ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number NI75TCDH

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2020

Event Type  malfunction  

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.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 a supraventricular tachycardia (svt) procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter, and the biosense webster, inc.Product analysis lab identified that the distal tip was cracked.During the procedure, the catheter could not deflect to specification.A second catheter was used to complete the procedure.No patient consequence was reported.The curve inadequate issue was assessed as not mdr reportable.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 on may 14, 2020 it was identified that the distal tip was bent and cracked.The device integrity was compromised; however, since there was no mention of any damage to the integrity of the device in the event description, multiple attempts were made to obtain clarification to this returned condition.No further information has been made available.Therefore, with the information available, this returned condition is assessed as an mdr reportable issue.The awareness date for this issue is may 14, 2020.

Manufacturer Narrative

On (b)(6)2020 , the product investigation was completed.It was reported that a patient underwent a supraventricular tachycardia (svt) procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter, and the biosense webster, inc.Product analysis lab identified that the distal tip was cracked.During the procedure, the catheter could not deflect to specification.A second catheter was used to complete the procedure.No patient consequence was reported.The curve inadequate issue was assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.Device evaluation details: the device was visually inspected and it was found that the distal tip was bent and cracked.A second closer inspection was performed and identified that the peek housing was also bent and cracked.Additional internal parts can be observed.Then, deflection test was performed and it was found within specifications: the catheter was deflecting correctly.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint cannot be confirmed.The root cause of the peek housing bent and cracked cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the handling of the device during the procedure, however, this cannot be conclusively determined.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc-000689528.

Manufacturer Narrative

On june 12, 2020, biosense webster, inc.Became aware that the g section "date received by manufacture" field was mistakenly indicated as "6/11/2020" on the previous supplemental report.The corrected date received by manufacture date is 5/21/2020.The previous supplemental report has been submitted on time per mdr reporting guidelines.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Initially, this complaint was reported as the biosense webster, inc.Product analysis lab identified that the distal tip was cracked.Additional information was received on 6/23/2020 which clarified that the damage of the distal tip was inflicted post-procedure.Therefore, this lab finding is being re-assessed to not mdr reportable.Manufacturer's reference number: (b)(4).

• Brand Name: NAVI-STAR THERMO-COOL ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 10141546
• MDR Text Key: 196083233
• Report Number: 2029046-2020-00685
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835000559
• UDI-Public: 10846835000559
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2022
• Device Model Number: NI75TCDH
• Device Catalogue Number: NI75TCDH
• Device Lot Number: 30286765M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2020
• Date Manufacturer Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND CATHETER