MAUDE Adverse Event Report: I-FLOW, LLC SILVERSOAKER CATHETER 2.5 IN

Model Number PM025-A

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

Patient Problems Unspecified Infection (1930); Foreign Body In Patient (2687)

Event Date 03/03/2014

Event Type  Injury  

Event Description

Drug/diluent: not applicable.Fill volume: not applicable.Flow rate: not applicable.Procedure: bilateral abdominoplasty.Cathplace: bilateral abdomen.Date of surgery: (b)(6) 2014.A physician/surgeon placed a call to our sales rep to report a catheter break.The pt underwent abdominoplasty and the catheters were placed bilaterally in the abdomen.One of the silversoaker catheters was removed without any problem and intact while the other one broke at the 3 marks estimated (15cm) during removal.Add'l info rec'd (b)(6) 2014 per catheter complaint intake form: (incident as described) "pt underwent surgery to remove foreign body, this was unsuccessful, now having wound post operative infection/delay wound healing problem." did the pt experienced discomfort during removal - yes.Both black marking of the catheter were not present, it is estimated that the soaker part and to the 3rd marking is retained inside the pt.The retained segment has not been removed.Catheter was not sutured through.Catheter was secured to the pt with surgical dressing.A hemostat device was used to remove the catheter.It was rated a 5 for resistance met on a scale of 0-5 (5= extreme resistance) met during catheter removal.The catheter was reported to be removed with gentle continuous traction.Did any part of the catheter appear to be stretched, clean cut or grayish white - no.No sample available for return.Lot info is not available.Info rec'd from the physician: the catheter was left in, pt is still recovering with wound vac.From a staph infection.I think it is unrelated, procedure was done in our office facility.Add'l info rec'd (b)(6) 2014: nurse provided info that the pt had a wound dehiscence and an infection on her left abdomen, wound measures 12cm x 2cm x2.5cm lxwxd.Culture of the wound was taken on (b)(6) 2014 and revealed growth of organisms.The pt went through another wound debridement surgery and a woundvac has been used for treatment.This infection is unlikely caused by the catheter remnant.A ct scan showed the catheter remnant inside the pt.The surgeon has decided not to remove it at this point.

Manufacturer Narrative

Method: it was reported that the sample will not be returned to the manufacture.The lot number was not provided, therefore, a review of the device history records (dhr) could not be conducted.Results: a device was unavailable for an eval, as a result, no methods were performed; therefore, results cannot be obtained.Conclusions: the device was not returned to i-flow for eval, therefore, we are unable to determine a cause for the reported event.Add'l investigations will be performed with the reported info provided.If add'l info pertinent to this event becomes available, i-flow will submit a f/u report.Info from this incident will be included in our product complaint and mdr trend reporting system.Add'l investigation may arise from ongoing analysis, trend info, or other analysis as appropriate.

• Brand Name: SILVERSOAKER CATHETER 2.5 IN
• Type of Device: CATHETER
• Manufacturer (Section D): I-FLOW, LLC; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 3783874
• MDR Text Key: 4442039
• Report Number: 2026095-2014-00047
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2014

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: PM025-A
• Device Catalogue Number: 101371800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2014
• Initial Date FDA Received: 04/15/2014
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 70