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

Catalog Number 301803MS

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2018

Event Type  malfunction  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.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.The device history record (dhr) has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.(b)(4).

Event Description

It was reported that during an svt procedure, the preface sheath was pierced by the internal sheath.There was no issue with the catheter.The preface sheath was replaced to complete the procedure and no patient consequence reported.Additional information was received on 2/28/2018 indicating the sheath got perforated while introducing the internal sheath.Biosense webster inc.(bwi) has determined if there¿s a perforation on the sheath caused by the needle or dilator, then there¿s a potential for cardiac/vascular injury due to misalignment of the needle/dilator to the intended path.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 4/2/2018.Initial visual analysis indicates the returned product appears in normal condition.No perforations were found on the sheath.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).

Manufacturer Narrative

It was reported that during an svt procedure, the preface sheath was pierced by the internal sheath.There was no issue with the catheter.The preface sheath was replaced to complete the procedure and no patient consequence reported.Product evaluation details: the device was visually inspected and it was found in good conditions.The customer complaint cannot be confirmed.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 ref # (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: 7374647
• MDR Text Key: 103943477
• Report Number: 2029046-2018-01355
• Device Sequence Number: 1
• Product Code: DYB
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2018

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: 06/30/2018
• Device Catalogue Number: 301803MS
• Device Lot Number: 17692158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Initial Date Manufacturer Received: 02/26/2018
• Initial Date FDA Received: 03/27/2018
• Supplement Dates Manufacturer Received: 04/02/2018; 06/05/2018
• Supplement Dates FDA Received: 04/06/2018; 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1