MAUDE Adverse Event Report: HALYARD - IRVINE 7.5 INCH SILVERSOAKER SET; CATHETER

Model Number UNKNOWN

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 07/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Udi # unknown.The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.(b)(4).

Event Description

A report as received stating the surgeon placed the sheath inside the patient and closed the incision site.After the surgeon had placed the catheter through the sheath, the surgeon attempted to peel away the sheath.It broke with a partial piece of the sheath retained inside the patient.The surgeon made an incision on the patient to retrieve the sheath, when doing so, it is not sure if the sheath was indeed sutured in.Additional information received 20-jul-2016 stated the device was it is not sure if the sheath was indeed sutured in.When the sheath remnant was removed from the patient, a part of it seem to be violated.The clinicians concluded that it might have been caught in the suture.After the sheath was broken, a small incision was made to retrieve the sheath remnant, but was unsuccessful.A part of the original incision was then reopened to remove the sheath remnant.No additional information was provided.

• Brand Name: 7.5 INCH SILVERSOAKER SET
• 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, bc 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5882173
• MDR Text Key: 52317993
• Report Number: 2026095-2016-00122
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/20/2016

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: Physician
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2016
• Initial Date FDA Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 68 YR
• Patient Weight: 98