MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ); ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION

Model Number	D-1270-05-S
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bwi failure analysis lab received the device for evaluation.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).
Event or Problem Description
It was reported that a patient underwent a procedure with an ez steer non-nav 4mm catheter for which the packaging was discovered to be open at the top.During the procedure, it was found that the pouch seal was compromised, though the box had never been opened.The catheter from the box with the open pouch seal was noted to have compromised sterility as a result.It was never placed into the sterile field, nor did it come into contact with the patient.A new catheter was used to complete the procedure, which completed without any patient consequences.Packaging defects compromise the sterility of the product, potentially exposing the patient to the introduction of microorganisms into the vasculature.Possible consequences of this exposure are infection and sepsis, which may result in the patient needing to receive additional medical intervention to preclude permanent injury or impairment.As a result, this issue is mdr reportable.
Additional Manufacturer Narrative
(b)(4).It was reported that a patient underwent a procedure with an ez steer non-nav 4mm catheter for which the packaging was discovered to be open at the top.The returned device was visually inspected upon receipt and the supplier seal end was found open with foreign purple liquid stains, as well as an oily appearance on the plastic and white tyvek material.Evidence of heat transfer was observed.A fourier transform infrared spectroscopy (ft-ir) test was performed in order to identify the type of liquid material observed; the results demonstrated that the purple material found was primarily composed of aliphatic ester-base material.During the manufacturing process, there is no purple substance with an oily appearance used, and on line inspections are in place to prevent open pouches.As part of the investigation, a pull test was performed at the still-sealed pouch areas, and the strength value was found within specification.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 dhr was expanded to the receiving inspection sample and all the pieces successfully passed the pull test performed.A report was run in order to find complaints with the same characteristics in the lot number reported, but no other complaints were found.The packaging issue reported appears to be the result of an improper product handling in someplace external to the manufacturing environment.The customer complaint has been verified.The root cause does not appear to be manufacturing related.

• Common Device Name: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• MDR Report Key: 5758842
• Report Number: 9673241-2016-00409
• Device Sequence Number: 628714
• Product Code: LPB
• UDI-Device Identifier: 10846835002515
• UDI-Public: (01)10846835002515(11)160416(17)190331(10)17453801M
• Combination Product (Y/N): N
• PMA/510(K) Number: P950005/S19
• 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
• Report Date (Section B): 06/06/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: D-1270-05-S
• Device Catalogue Number: BD7TCDF4L
• Device Lot Number: 17453801M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/29/2016
• Supplement Report FDA Received Date: 09/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1