MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE) NAVISTAR? ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Model Number D-1183-07-S

Device Problem Occlusion Within Device (1423)

Patient Problems Neurological Deficit/Dysfunction (1982); Thrombus (2101)

Event Date 01/21/2015

Event Type  Injury  

Event Description

It was reported that a male patient, underwent an atrial fibrillation procedure with a navistar¿ electrophysiology catheter and clot was found on the tip of the catheter after the procedure.The patient also suffered symptoms of cerebrovascular accident.There is no further information about the hospitalization and if any additional intervention was performed.The patient¿s medical history is unknown.The patient was reported to be in stable condition and was now fully recovered.The physician did not provide a causality opinion for the cause of this adverse event.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.The device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Since the lot number is unknown, the full udi number cannot be provided.Manufacturer's reference #(b)(4) is related to the same event.Manufacturer's reference # (b)(4).

• Brand Name: NAVISTAR? ELECTROPHYSIOLOGY 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: jaime chavez ; 9098398483
• MDR Report Key: 4618374
• MDR Text Key: 16991611
• Report Number: 2029046-2015-00059
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2015

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-1183-07-S
• Device Catalogue Number: NS7TCDL174HS
• Device Lot Number: UNKNOWN_D-1183-07-S
• Other Device ID Number: (01)10846835000597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2015
• Initial Date FDA Received: 03/19/2015
• 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): Life Threatening