MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problems Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2021

Event Type  malfunction  

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 Description

It was reported that an unknown patient underwent an unknown ablation procedure with a thermocool¿ smart touch¿ sf bi-directional navigation catheter.The packaging was damaged, and the pouch has a hole in it.The outer packaging of the catheter was damaged as the nurse took it out of the box.Damaged package led to an unsterile catheter because of hole in sterile pouch.The damaged packaging is mdr-reportable.

Manufacturer Narrative

On 5/18/2021, the product investigation was completed for a received photo of the complaint device as the physical device was not received.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed (for the physical device).Device investigation summary: it was reported that the outer packaging of the catheter was damaged as the nurse took it out of the box.Damaged package lead to unsterile catheter.According to the picture provided by the customer, a rupture was observed in the distal section of the sterile package.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.The customer complaint was confirmed.This investigation was performed based only on the photo provided.If the product is received after this investigation, an assessment will be performed as per the conditions of the device returned.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 7/3/2021, 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).

Manufacturer Narrative

On 1-aug-2021, the product investigation was completed.It was reported that an unknown patient underwent an unknown ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The packaging was damaged, and the pouch has a hole in it.The outer packaging of the catheter was damaged as the nurse took it out of the box.Damaged package led to an unsterile catheter because of hole in sterile pouch.Device evaluation details: according to the picture provided by the customer, a rupture was observed in the the distal section of the sterile package.Additionally, the product was returned to biosense webster for evaluation.Bwi conducted a visual inspection evaluation of the returned device.Visual analysis of the returned sample revealed the pouch damage.For this condition a meeting was performed with the manufacturing team in order to find the root cause, the investigation determined that it is possible that the failure condition reported was caused after the packaging and shipping process.At this time is not possible to determine the root cause of this condition, however based on the information provided, the condition reported have origin in some place external to the manufacturing environment since all the control points, inspections and executions were found correctly executed.A manufacturing record evaluation was performed for the finished device [30509331l] number, and no internal actions related to the reported complaint condition were identified.It was reported that the outer packaging of the catheter was damaged as the nurse took it out of the box.Damaged package lead to unsterile catheter.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: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11764777
• MDR Text Key: 266283018
• Report Number: 2029046-2021-00702
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30509331L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2021
• Date Manufacturer Received: 08/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1