MAUDE Adverse Event Report: HALYARD ON-Q EXPANSION KIT: SILVER SOAKER 5IN (12.5CM); CATHETER

Model Number PM020-A

Device Problems Stretched (1601); Split (2537); Torn Material (3024)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/01/2015

Event Type  Injury  

Event Description

Procedure: flap reconstruction.Cathplace: left-side breast.It was reported by a pt's husband that a silver soaker catheter became stretched and broke upon removal.It was reported that a high amount of resistance was met during removal (4 out of 5).The break was located 2 notches away from the tim of the catheter.The pt underwent surgery on (b)(6) 2015 for a total of 40 minutes to remove the retained catheter piece.The pt's hospitalization was extended for 2 add'l days.Further clarification and add'l info was rec'd on (b)(6)2015.The pt has 2 catheters placed in the breast tissue on each side.The nurse easily removed the catheter on the right side with no incident.When removing the catheter on the left side, resistance was met.The nurse then stopped and obtained the surgeons assistance.When the surgeon made an attempt to remove the catheter, the catheter broke.Later that day ((b)(6)2015) around 1pm an x-ray was taken to locate rhe broken segment.However, it was not visible on x-ray.On monday ((b)(6)2015), the surgeon opened up the top stitches from the surgical site in attempt to retrieve the retained catheter; however, he could not fine the catheter.The stitches were closed and 2 more x-rays were taken that day.The x-ray images did not show the retained catheter; however, an unused catheter was tested under x-ray and could be seen.No further imaging was performed.On (b)(6) ((b)(6) 2015), the pt underwent another surgery to remove the retained catheter.The surgeon had to go into a deeper layer where the catheter was originally placed, to locate the retained segment and remove it.The husband confirmed that the suture had held the catheter in place.The pt's recovery time and hospitalization stay was extended by a couple of days due to the incident.The pt is doing better and is currently in stable condition.The catheter pieces are available for return and eval.

Manufacturer Narrative

Method: at this time halyard is pending the receipt of the device.A review of the device history record (dhr) is in progress for the reported lot number rec'd.Results: results will be provided once testing and eval of the rec'd device have been completed.Conclusion: the investigation is ongoing, once completed a follow-up report will be submitted.Info from this incident has been included in our prod complaint and mdr trend reporting sys.Trend info is used to identify the need for add'l investigations.

• Brand Name: ON-Q EXPANSION KIT: SILVER SOAKER 5IN (12.5CM)
• Type of Device: CATHETER
• Manufacturer (Section D): HALYARD; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery; ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4567359
• MDR Text Key: 5550790
• Report Number: 2026095-2015-00082
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Model Number: PM020-A
• Device Catalogue Number: 101353501
• Device Lot Number: 0201368295
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DRUG: N/A
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Weight: 75