MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) WEBSTER? ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PACEMAKER, TEMPORARY

Model Number D-1085-178-S

Device Problems Bent (1059); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/13/2013

Event Type  malfunction  

Event Description

It was reported that during this procedure the webster 10 pole catheter signal had much interference.The catheter was changed to another one to complete the procedure.There was no patient injury reported in this procedure.The initial complaint reported was not indicative of a reportable event.Upon visual inspection of the returned complaint catheter on (b)(4) 2014, the bwi failure analysis lab noted that the electrode ring # 3 was sharp on the proximal side and material was bent next to the electrode ring #3.On the distal side of electrode ring #3, material and the pu margin were cut.The returned catheter condition was not reported initially.Additional clarification was requested on the returned condition, but no additional information has been provided.The returned catheter condition is indicative of a reportable event thus marking (b)(6) 2014 as the awareness date for this report.

Manufacturer Narrative

Investigation still in progress.A supplemental report or device evaluation will be submitted.(b)(4).

• Brand Name: WEBSTER? ELECTROPHYSIOLOGY CATHETER
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 3259 9; MX 32599
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3600729
• MDR Text Key: 4189700
• Report Number: 9673241-2014-00029
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K892265
• 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: 12/21/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Model Number: D-1085-178-S
• Device Catalogue Number: F5ADP282RT
• Device Lot Number: 15739767M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2013
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/03/2012
• 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