MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q CATHETER SILVERSOAKER 5IN (12.5CM)

Model Number PM020-A

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/08/2015

Event Type  Injury  

Event Description

Procedure: colectomy ((b)(6) 2015).Cathplace: bilateral abdomen.It was reported by a facility that a catheter broke inside a patient.The patient returned to outpatient surgery to have the catheters removed the morning of (b)(6) 2015.One catheter was removed without any issue.Resistance was met upon removal of the second catheter.When the catheter was pulled with more force, it broke with a portion of the catheter left inside the patient.It was not reported what the plan for the retained catheter is at this time.It was reported that the device was most likely a pm020-a.The lot number is not known at this time.The patient is reported as doing fine at the time of this report.The device is available for return.

Manufacturer Narrative

(b)(4).Method: the device was reported to be returning for an evaluation and at this time is pending return.The lot number was not provided; therefore, the review of the device history record (dhr) cannot be performed at this time.Results: at this time the investigation is still in progress.Once the device is received, testing will be performed and results will be provided once completed.Conclusions: once the investigation and device analysis are completed a follow-up report will be submitted.Information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.

Manufacturer Narrative

Method: a visual inspection, tensile strength test and microscopic inspection was performed on the returned device.Results: the silver-soaker catheter was returned not fully intact, missing the black catheter tip and infusion segment.The diameter where the breakage occurred was measured to be 0.029¿.The non-broken part was measured to be 0.043¿.The silver-soaker catheter was examined under a microscope magnified at 0.7x, no signs of brittleness were observed.Evidence revealed that stretching was observed where the breakage occurred.Tensile strength was performed on the silver-soaker catheter.The result for the catheter mid-body segment was 10.440(lbf).The tensile strength was not performed on the infusion segment because it was not returned.The passing rate for the test is >2.8(lbf) at the infusion segment and >4.00 (lbf) for the mid-body segment.The catheter met specifications during the tensile test and no additional testing was performed.Conclusion: evidence revealed that stretching was observed where the breakage occurred.Tensile strength testing was performed on the mid-body segment and it met specifications.It was reported that the catheter was pulled with more force, it then broke with partial catheter remaining inside the patient.Using excessive force >4.00(lbf) on the catheter at the mid-body segment and >2.8(lbf) at the infusion segment will cause it to break.Root cause was determined to be the incorrect use by the user.The instructions for use and the technical bulletin state to if catheter stretches to stop because continued pulling could break the catheter.The technical bulletin ( tips for preventing in-situ catheter breakage with the on-q* pain relief system, mk 00021) and instructions for use (on-q* catheters and introducers (14-60-602-0-04)) was sent to the customer with their closure letter.Information from this incident has been included in our product complaint trend reporting systems for monitoring, tracking and trending purposes.

• Brand Name: ON-Q CATHETER SILVERSOAKER 5IN (12.5CM)
• Type of Device: CATHETER
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana, b.c.
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4957873
• MDR Text Key: 6251496
• Report Number: 2026095-2015-00208
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK051401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM020-A
• Device Catalogue Number: 101353500
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2015
• Initial Date FDA Received: 07/31/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Weight: 79