MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (IRWINDALE) NAVISTAR; SIMILAR DEVICE NS7TCBL174HS, PMA # P990025

Model Number D-1183-00

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 08/03/2013

Event Type  Injury  

Manufacturer Narrative

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.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.Since no lot number was provided, no device history record (dhr) review could be performed.Concomitant product: circular ablation circ loop (model# d-1322-14-si lot# 15827526l).(b)(4).

Event Description

During a clinical trial sponsored by bwi, was reported that a (b)(6) male patient underwent an ablation procedure for paroxysmal atrial fibrillation with a navistar thermocool catheter and suffered dislodgement of permanent pacing leads requiring extraction and replacement.More than 7 days post-procedure, the patient¿s permanent pacing leads became dislodged from the right atrium and right ventricle.Patient returned to the facility and had them extracted and replaced.Patient required hospitalization as a result of this adverse event, but not extended hospitalization.Issue resolved without sequelae.Principal investigator assessed this event as mild in severity, serious, not device-related, and definitely index procedure-related.

• Brand Name: NAVISTAR
• Type of Device: SIMILAR DEVICE NS7TCBL174HS, PMA # P990025
• 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: 6653640
• MDR Text Key: 78019971
• Report Number: 2029046-2017-00198
• 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: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1183-00
• Device Lot Number: UNKNOWN_NAVISTAR TC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2013
• 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; Required Intervention
• Patient Age: 77 YR