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

Model Number	D135304
Medical Device Problem Codes	Material Puncture/Hole (1504); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent cardiac ablation for atrial fibrillation (afib) procedure with a webster cs catheter with auto id technology where punctured pouch occurred.It was reported that the webster cs catheter with auto id technology clear plastic packaging was punctured near the handle of the catheter.There was no confirmation whether the puncture went all the way through the packaging.The catheter was not used and was replaced.The procedure continued.There was no report of patient consequence.An image was received by bwi, which shows a potential perforation of the sterile pouch.A punctured pouch is an mdr-reportable issue.
Additional Manufacturer Narrative
On 11/30/2020, the bwi product 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2020, the product investigation was completed.It was reported that a patient underwent cardiac ablation for atrial fibrillation (afib) procedure with a webster cs catheter with auto id technology where punctured pouch occurred.It was reported that the webster cs catheter with auto id technology clear plastic packaging was punctured near the handle of the catheter.There was no confirmation whether the puncture went all the way through the packaging.The catheter was not used and was replaced.The procedure continued.There was no report of patient consequence.Device evaluation details: according to pictures provided by customer, pouch appeared damaged.The physical device was visually inspected and it was found in good conditions.It was not possible to perform the failure analysis since the packaging was not returned.A manufacturing record evaluation was performed for the finished device 30253707m number, and no internal action related to the complaint was found during the review.Customer complaint was confirmed based on the picture received.The packaging has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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: 10852487
• Report Number: 2029046-2020-01732
• Device Sequence Number: 16361629
• Product Code: DRF
• UDI-Device Identifier: 10846835009989
• UDI-Public: 10846835009989
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K080425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2020

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: 07/10/2022
• Device Model Number: D135304
• Device Catalogue Number: D135304
• Device Lot Number: 30253707M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 11/30/2020; 12/23/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 12/07/2020; 01/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1