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

Model Number D134805

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.A manufacturing record evaluation was performed for the finished device with lot number 30273545m, and no internal actions related to the reported complaint condition were identified.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and it was reported that the sterile packaging was compromised.It was reported that the sterile packaging was found torn prior to opening package.The catheter was exchanged, and they continued with the procedure.Product never used on patient.No patient consequences were reported.The open pouch seal issue was assessed as an mdr reportable malfunction.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

On january 30, 2020, the biosense webster, inc.Product analysis lab received the device for evaluation and upon initial visual inspection it was noted that the catheter was still in its original pouch and has never been opened.The pouch was intact, and seal was not broken.This returned condition was assessed as not reportable as there was no noted damage to the pouch as initially reported by the customer.The lot # on the sealed pouch (30273545m) does not match the lot # on the outer packaging box (30266335m) that the device was sent in.Therefore, further clarification on the device received has been requested.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 # (b)(4).

Manufacturer Narrative

Investigation summary
=
> it was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and it was reported that the sterile packaging was compromised.It was reported that the sterile packaging was found torn prior to opening package.The catheter was exchanged, and they continued with the procedure.Product never used on patient.No patient consequences were reported.Upon receipt, the complaint was inspected, and it was found that the pouch torn.However, the pouch was received sealed correctly.For the condition of pouch torn, the manufacture team performed an investigation in order to find the root cause.The investigation results showed that it is probable that the failure condition reported was caused after the packaging and shipping process due the lot involved was verified.The control points, inspections and executions were found correctly executed.A manufacturing record evaluation was performed for the finished device with lot number 30273545m, and no internal actions related to the reported complaint condition were identified.Customer complaint regarding bag being torn before opening the package has been confirmed.The root cause the torn bag cannot be related with the manufacturing process since all the control points, inspections and executions were found correctly executed.Manufacturer's reference #
=
> pc-(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: 9535927
• MDR Text Key: 200062204
• Report Number: 2029046-2019-04084
• 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
• Report Date: 12/08/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2020
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30273545M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Initial Date Manufacturer Received: 12/08/2019
• Initial Date FDA Received: 12/31/2019
• Supplement Dates Manufacturer Received: 01/30/2020; 03/24/2020
• Supplement Dates FDA Received: 02/24/2020; 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1