MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (IRWINDALE) WEBSTER

Model Number D-1078-00

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Diaphoresis (2452)

Event Date 10/06/2016

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Since no lot number was provided, no device history record (dhr) review could be performed.(b)(4).

Event Description

It was reported that a (b)(6) male patient underwent an idiopathic ventricular tachycardia ablation procedure for premature ventricular contractions (pvcs) with a webster 10 pole catheter and suffered a cardiac tamponade requiring pericardiocentesis.After ablation was completed, the patient became hypotensive and diaphoretic.A tamponade was confirmed via soundstar ultrasound catheter.The patient was reported to be in stable condition at the time of complaint report.The patient did not require extended hospitalization as a result of this adverse event.The patient has since fully recovered.There were no factors cited that may have contributed to the adverse event.The physician¿s opinion regarding the cause of the adverse event was that it was procedure-related.The physician believes that the injury was a result of advancing the webster cs catheter too far into the coronary sinus, resulting in the rupture of the distal portion of the coronary sinus.No transseptal puncture was performed.Sheath used was a (b)(4) agilis 8.5 french.Generator parameters at the time of injury: power control mode at 30 watts, not titrated, with cutoff at 50 watts.Temperature was at 41°c, with a cutoff at 50°c.The impedance was at 121 ohms.The overall ablation time and last ablation cycle time at the site of injury were not reported, as there was no ablation at the site of injury.Irrigated catheter flow was set at 17ml/min during ablation up to 30 watts.Ablation did not exceed 30 watts.The patient received anticoagulant during the procedure with activated clotting times maintained between 300-350 seconds.Spi value was zero.Smarttouch catheter was not in close proximity to another catheter.Smarttouch catheter was zeroed after the initial warm-up phase, post-connection to the carto 3 piu.Carto 3 system did not indicate to re-zero the catheter.There were no error messages observed on any bwi equipment during the procedure.

Manufacturer Narrative

Additional information was received on november 9, 2016 that a webster decapolar was not used during the procedure.A bard dynamic decapolar catheter was actually used.The catheter and the box were disposed of after the case.Therefore this event is not mdr reportable for any biosense webster inc.(bwi) products since the physician believes that the injury was a result of advancing the cs catheter too far into the coronary sinus, resulting in the rupture of the distal portion of the coronary sinus.The cs catheter used was not a bwi device.(b)(4).

• Brand Name: WEBSTER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6067265
• MDR Text Key: 58817374
• Report Number: 2029046-2016-00240
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2016

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 Model Number: D-1078-00
• Device Catalogue Number: D107800
• Device Lot Number: UNKNOWN_WEBSTER DECAP - DEFL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/06/2016
• Initial Date FDA Received: 10/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 80