MAUDE Adverse Event Report: I-FLOW CORP. N-Q CATHETER EXPANSION KIT: SILVERSOAKER 5IN; SILVER SOAKER CATHETER

Model Number PM020-A

Device Problems Stretched (1601); Split (2537)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/19/2014

Event Type  Injury  

Event Description

Drug/diluent: na.Fill volume: na.Flow rate: na.Procedure: 14-5 posterior lumber fusion.Cathplace: bilateral placement lateral to mid-line spinal fusion.Date of surgery: (b)(6) 2014.A surgeon reported a catheter that broke during removal.The pt had bilateral catheter placement lateral to mid-line spinal incision.The broken catheter appeared stretched.The sample is available for return.Add'l info received (b)(6) 2014; the physician's assistant provided that the pt was returned to surgery 2 days after the catheter broke for a revision of the spinal surgery and removal of the catheter remnant.The catheter remnant was not found.Per catheter break questionaire received, both markings were not present upon removal and it is estimated 2.5" is retained inside the pt.The catheter appeared to be stretched.

Manufacturer Narrative

Method: at this time we are pending the receipt of the device, therefore, no testing methods have been performed.The device history records (dhr) cannot be reviewed without a lot number, which was asked for but not provided.Results: at this time, the eval is still in progress.Results will be provided once completed.Conclusions: at this time i flow is pending the return of the device for an eval.The investigation is ongoing, once completed a f/u report will be submitted.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: N-Q CATHETER EXPANSION KIT: SILVERSOAKER 5IN
• Type of Device: SILVER SOAKER CATHETER
• Manufacturer (Section D): I-FLOW CORP.; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery, ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 3708504
• MDR Text Key: 4263690
• Report Number: 2026095-2014-00030
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/19/2014

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?: No
• Device Operator: Health Professional
• Device Model Number: PM020-A
• Device Catalogue Number: 101353500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2014
• Initial Date FDA Received: 03/17/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 68