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

Model Number D-1245-00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pericardial Effusion (3271)

Event Date 12/31/2011

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the no lot number was provided by the customer.Concomitant products were used during this study: carto 3 mapping system, preface sheath, deca-nav catheter.Evaluation methods: no testing methods performed; (b)(4).Results: no results available since no evaluation performed; (b)(4).Conclusion: device discarded by user, unable to follow-up; (b)(4).

Event Description

This complaint is from a literature source.It was reported that a (b)(6) patient underwent an radiofrequency ablation for ventricular tachycardia and developed a small pericardial effusion¿attributed to concomitant pericardial access¿and 250 ml of bloody fluid was drained from the pericardium at the end of the procedure from the preexistent pericardial access.The patient underwent cardiac magnetic resonance imaging 48 hours post procedure.It revealed significant expansion of basal anteroseptal hyperenhancement, indicative of ethanol-induced injury.Based on the facts of the case and the author¿s assessment, there were no reported malfunction with any of the bwi catheters and systems used during the case.Thus, this event is unrelated to the device and most likely related to the procedure.Title: ¿retrograde coronary venous ethanol infusion for ablation of refractory ventricular tachycardia.¿ the purpose of this study was to report its combination with venous wire mapping in a variety of vt substrates, particularly the lv summit, and report its chronic outcomes.Seven (7) patients were included in this study.Suspect device is pentaray catheter, however catalog and lot number are unknown.

• Brand Name: GENERIC - PENTARAY
• Type of Device: GENERIC - PENTARAY
• 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: 6012532
• MDR Text Key: 56939095
• Report Number: 2029046-2016-00216
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• 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
• Date Manufacturer Received: 09/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 65 YR