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

Catalog Number	D135304
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2018
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.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrioventricular reentrant tachycardia (avrt)/(wpw) procedure with a webster cs catheter with auto id technology and foreign material was found on the tip of the catheter.The physician performed an atrioventricular reentrant tachycardia procedure post in the right atrium.At the end of the procedure, the physician took out the catheters and noted that something was attached to the tip proximal part of the distal electrode of the webster cs catheter with auto id technology.The physician tried to pull the unknown material back; however, it stayed attached.The physician¿s opinion was that this unknown material attached at the proximal part of the distal electrode was a wire from the catheter itself.The catheter was then being handed over to the biosense webster field representative and this unknown material fell off of the catheter.There was no patient consequence reported.After reviewing the information,the picture provided of the catheter and the unknown material, this unknown material was assessed as foreign material and has been assessed as a reportable issue.
Additional Manufacturer Narrative
Investigation summary: it was reported that a patient underwent an atrioventricular reentrant tachycardia (avrt)/(wpw) procedure with a webster cs catheter with auto id technology.The physician performed an atrioventricular reentrant tachycardia procedure post in the right atrium.At the end of the procedure, the physician took out the catheters and noted that something was attached to the tip proximal part of the distal electrode of the webster cs catheter with auto id technology.The physician tried to pull the unknown material back; however, it stayed attached.The physician¿s opinion was that this unknown material attached at the proximal part of the distal electrode was a wire from the catheter itself.The catheter was then being handed over to the biosense webster field representative and this unknown material fell off of the catheter.There was no patient consequence reported.The device was visually inspected and it was found in good condition, no foreign material was observed, no internal parts were observed exposed.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 customer complaint cannot be confirmed.Manufacturer's reference number:(b)(4).

• Brand Name: WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8076065
• Report Number: 2029046-2018-02289
• Device Sequence Number: 19262752
• Product Code: DRF
• UDI-Device Identifier: 10846835009989
• UDI-Public: 10846835009989
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K080425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2018

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 Catalogue Number: D135304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1