MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (IRWINDALE) WEBSTER® CS CATHETER WITH AUTO ID TECHNOLOGY; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number D-1353-04-S

Device Problem Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2017

Event Type  malfunction  

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 no lot number was provided by the customer.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a webster coronary sinus with auto id catheter.It was reported that the packaging of the catheter had its sterility compromised from an open bag.This catheter was not used in the patient and was exchanged.The procedure was completed with no patient consequence.This event has been assessed as a reportable malfunction as this presents the possibility of introduction of microorganisms into the vasculature which may lead to an infectious process, bacteremia or sepsis.This may result in the need for additional medical intervention or injury.

Manufacturer Narrative

Manufacturer's reference number: (b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a webster coronary sinus with auto id catheter.It was reported that the packaging of the catheter had its sterility compromised from an open bag.This catheter was not used in the patient and was exchanged.The procedure was completed with no patient consequence.The returned device was visually inspected and it was found in normal conditions.However, the packaging with the pouch was not returned for analysis.Per this condition, no analysis could be performed.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.During the manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of damage from leaving the facility.The customer complaint cannot be confirmed since the packaging was not returned.However, there is evidence that the device was manufactured in accordance with documented specification and procedures.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 8/25/17.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.Manufacturer's ref.No: (b)(4).

• Brand Name: WEBSTER® CS CATHETER WITH AUTO ID TECHNOLOGY
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, 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: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6644963
• MDR Text Key: 77836602
• Report Number: 2029046-2017-00192
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K080425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D-1353-04-S
• Device Catalogue Number: D135304
• Device Lot Number: UNKNOWN_D-1353-04-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/17/2017
• Initial Date FDA Received: 06/15/2017
• Supplement Dates Manufacturer Received: 05/17/2017; 05/17/2017
• Supplement Dates FDA Received: 08/30/2017; 10/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1