MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Model Number	D-1183-20-S
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); No Code Available (3191)
Date of Event	04/21/2017
Type of Reportable Event	Serious Injury
Additional 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.The device history record (dhr) for the lot number 17645035m has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Concomitant products: carto 3 system, model #: m-4800-01.Serial #: (b)(4).Lasso navigational variable eco catheter, model #: d-1343-01-s, lot #: 17631996l.Distributed -acunav ultrasound catheter, model #: m-5723-07, lot #: g2051556.(b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure for atrial fibrillation with a navistar catheter and suffered an st segment elevation myocardial infarction requiring a cardiac catheterization and an impella left ventricular assist device (lvad).During the procedure, the patient became hypotensive and the ecg revealed st segment elevation (leads unspecified).Left-sided cardiac catheterization revealed coronary spasm.Impella left ventricular assist device (lvad) was implanted.Patient was reported to be in stable condition.Patient was admitted to the intensive care unit.There is no information regarding extended hospitalization.There is no information regarding patient outcome.Physician¿s opinion regarding the cause of the 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.
Additional Manufacturer Narrative
The bwi failure analysis lab received the device for evaluation on 5/19/2017.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.(b)(4).
Additional Manufacturer Narrative
(b)(4).It was reported that a patient underwent an ablation procedure for atrial fibrillation with a navistar catheter.During the procedure, the patient became hypotensive and the ecg revealed st segment elevation (leads unspecified).Left-sided cardiac catheterization revealed coronary spasm.Impella left ventricular assist device (lvad) was implanted.Patient was reported to be in stable condition.Patient was admitted to the intensive care unit.There is no information regarding extended hospitalization.There is no information regarding patient outcome.The returned device was visually inspected and it was found in normal conditions.The catheter was evaluated for carto 3 and it was recognized by the system, no error messages were displayed and the catheter was properly visualized.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.Then the catheter was tested for electrical performance and stockert compatibility and it was found within specifications.Additionally, a deflection and an irrigation test were performed and the catheter passed the tests.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The catheter passed all specifications.The root cause of the adverse event cannot be determined.However, per the physician¿s opinion the cause of the adverse event is that it was procedure-related.

• Brand Name: NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• MDR Report Key: 6566980
• Report Number: 9673241-2017-00374
• Device Sequence Number: 1049534
• Product Code: DRF
• UDI-Device Identifier: 10846835008586
• UDI-Public: (01)10846835008586(11)170224(17)200131(10)17645035M
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P990025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: D-1183-20-S
• Device Catalogue Number: NS7TCJL174HS
• Device Lot Number: 17645035M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/21/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/15/2017
• Supplement Report FDA Received Date: 05/22/2017; 06/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention