MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (IRWINDALE) PENTARAY HIGH-DENSITY MAPPING CATHETER; CATHETER, ELECTRODE RECORDING

Model Number D-1245-00

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Tachycardia (2095); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 06/10/2016

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Concomitant product: soundstar eco catheter, model #: m-5723-17.(b)(4).

Event Description

It was reported that a patient, (b)(6), female, underwent an idiopathic ventricular tachycardia - left (l-idvt) procedure with a smart touch bidirectional catheter and a pentaray catheter and suffered a cardiac tamponade which required a pericardiocentesis.While mapping in the left ventricle (lv) the patient suffered a pericardial effusion.All mapping performed was done with catheters in retrograde aortic.No ablation or transseptal had been performed.They initially mapped with a pentaray catheter and while mapping with the smart touch bidirectional catheter the patient became tachycardiac.A trace effusion was noted on intracardiac echocardiography (ice).The mapping continued.The tachycardia persisted and there were small fluctuations in the patient's blood pressure.A transthoracic echo was performed and a more prominent effusion was determined.At that point, they aborted the procedure and performed a pericardiocentesis withdrawing 100cc of fluid.The flow setting was set to 2ml/min.The st.Jude sr0 sheath was used.Heparin was used and the act was maintained at 300-350.The patient did require extended hospitalization as held overnight.The patient was reported to be in stable condition at the time the complaint was reported.The patient fully recovered with no residual effects.The physician's opinion regarding the cause of this adverse event is that it was procedure related.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.Also, since this issue occurred during the mapping phase, we are taking the conservative approach and reporting this event under both the catheters (smart touch bidirectional catheter and pentaray catheter) used during the mapping phase.

• Brand Name: PENTARAY HIGH-DENSITY MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING
• 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: 5769371
• MDR Text Key: 48777792
• Report Number: 2029046-2016-00082
• 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
• Report Date: 06/10/2016

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-1245-00
• Device Catalogue Number: D124500
• Device Lot Number: UNKNOWN_PENTARAY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/10/2016
• Initial Date FDA Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 54