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

Model Number D134702

Device Problems Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)

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

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

The product has not returned for analysis, however, a picture(s) were provided by the customer.Evaluation is still in progress.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).

Event Description

It was reported that a patient underwent and unknown ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and a sterilization compromised issue occurred.A hole in the inner, sterile packaging of thermocool® smart touch® sf uni-directional navigation catheter.Defective packaging was discovered by nurse prior to unpacking of catheter.Catheter was not used in patient.Procedure performed with new catheter.No harm to patient.Additional information was received on the event.Outer packaging of catheter was found in good shape when arrived at customer.Inner sterile packaging; however, was found to be damaged (hole in pouch).Pouch seal was opened by a hole.Top of pouch; however, appeared to be crinkled and crumbled.The hole on the pouch issue was assessed as a mdr reportable sterilization compromised issue.The pouch being crinkled and crumbled was assessed as not mdr for a package damaged issue.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.

Manufacturer Narrative

It was reported that a patient underwent and unknown ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and a sterilization compromised issue occurred.Outer packaging of catheter was found in good shape when arrived at customer.Inner sterile packaging; however, was found to be damaged (hole in pouch).Pouch seal was opened by a hole.Top of pouch; however, appeared to be crinkled and crumbled.Device investigation details: since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.However, the photograph investigation was completed on (b)(6) 2021.According to pictures provided by the customer, a small hole was observed in the pouch of the inner sterile packaging.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.Based on the customer¿s pictures, the 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 ref.# (b)(4) on (b)(6) 2021, after further review of the event details, it was determined the event should have been coded as an "open pouch issue".As such, the following h6.Medical device problem code changed have been processed: code "delivered as unsterile product (a020701)" and "packaging problem (a0205)" have been removed and "tear, rip or hole in device packaging (a020504)" has been added.

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) during an internal review on(b)(6) 2021, noted correction to 3500a follow-up #1 on the coding under ¿h6.Type of investigation as should have included in ¿h6.Type of investigation¿ the code for ¿device not returned (b17)¿.Therefore, processed this field accordingly.In ¿h10.Additional manufacturer narrative¿ should have included, ¿since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.¿.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on (b)(6)-2021.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

It was reported that a patient underwent and unknown ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and an open pouch issue occurred.A hole in the inner, sterile packaging of thermocool® smart touch® sf uni-directional navigation catheter.Defective packaging was discovered by nurse prior to unpacking of catheter.Catheter was not used in patient.Procedure performed with new catheter.No harm to patient.Additional information was received on the event.Outer packaging of catheter was found in good shape when arrived at customer.Inner sterile packaging; however, was found to be damaged (hole in pouch).Pouch seal was opened by a hole.Top of pouch; however, appeared to be crinkled and crumbled.The device evaluation was completed on 25-aug-2021.The product was returned to biosense webster for evaluation.Bwi conducted visual inspection of the returned device.Visual inspection was performed and it was found with a hole at the pouch.However, the pouch was found properly sealed.No other damage or anomalies were found.Based on the investigation, the reported condition could not be assignable to manufacturing process (packaging), as shown on the image below, the damage on the pouch matched with the damage on the tab of the unit carton and also with the damage on the luer hub this could be considered as a mishandling.It should be noted that product failure is multifactorial.The instructions for use contains the following precautions; the sterile packaging and catheter should be inspected prior to use.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.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 UNI-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: 11668395
• MDR Text Key: 256436512
• Report Number: 2029046-2021-00582
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• 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,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2022
• Device Model Number: D134702
• Device Catalogue Number: D134702
• Device Lot Number: 30500407L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Date Manufacturer Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND CATHETER