MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE; INTRODUCER, CATHETER

Catalog Number 301803M

Device Problem Backflow (1064)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2018

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.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a preface® guiding sheath with multipurpose curve and air flowed back into the side port.While introducing the ablation catheter up to the side port of the preface® guiding sheath with multipurpose curve, a small air bubble was noted pushing into the side port flush tubing.They pulled back on the side port and removed the air bubble.When reintroducing the ablation catheter, again the same issue occurred.The issue was resolved by replacing the sheath.There was no visible damage to the sheath.The procedure was continued.No patient consequences were reported.This issue of the air flowed back into the side port, was assessed as a reportable malfunction.

Manufacturer Narrative

The device history record and manufactured date have been provided on january 16, 2019.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.Manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent an atrial fibrillation (afib) procedure with a preface® guiding sheath with multipurpose curve and air flowed back into the side port.While introducing the ablation catheter up to the side port of the preface® guiding sheath with multipurpose curve, a small air bubble was noted pushing into the side port flush tubing.They pulled back on the side port and removed the air bubble.When reintroducing the ablation catheter, again the same issue occurred.The issue was resolved by replacing the sheath.There was no visible damage to the sheath.The procedure was continued.No patient consequences were reported.The device was visually inspected and it was found in good conditions.The preface® guiding sheath with multipurpose curve was flushed with water prior to the evaluation.A syringe was attached (filled with water) to the device to be flushed and the water flowed through the part and got out at the distal tip as expected, neither resistance to the water flow nor loose material was observed during the flushing procedure.A syringe was attached (filled with water) to the stopcock of the preface® guiding sheath with multipurpose curve.The distal section was clamped to avoid that the water would flow out of the distal tip.Positive and negative pressure was applied into the preface® guiding sheath with multipurpose curve and no leak of air or water was observed.Then, a catheter was inserted into the cannula, after that, positive pressure was applied into the preface® guiding sheath with multipurpose curve and no leaked of air or water was observed.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).

Manufacturer Narrative

Correction to the 3500a initial report was noted on (b)(6)2018.In the initial report it was reported that the "device history record (dhr) review cannot be conducted because no lot number was provided by the customer." however, the lot number was provided.Therefore, still pending is device history record.A supplemental report will be submitted.In addition, correction to device evaluated by mfr.Reason for non- evaluation field as it should have reflected as "device evaluation anticipated, but not yet begun".Also, method codes, result codes.Conclusion codes fields should have been blank.Manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

The biosense webster inc.Product analysis lab received the device for evaluation on (b)(6)2019.Therefore, populated device available for evaluation?, is device returned to manufacturer? and date device returned to manufacturer.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.Manufacturer's ref.No: (b)(4).

• Brand Name: PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8205515
• MDR Text Key: 131927987
• Report Number: 2029046-2018-02503
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835000047
• UDI-Public: 10846835000047
• Combination Product (y/n): N
• PMA/PMN Number: K982740
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/04/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 301803M
• Device Lot Number: 17748718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 12/30/2018
• Supplement Dates Manufacturer Received: 12/30/2018; 01/03/2019; 01/16/2019; 05/31/2019
• Supplement Dates FDA Received: 12/30/2018; 01/07/2019; 01/16/2019; 06/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1