MAUDE Adverse Event Report: I-FLOW LLC, SILVERSOAKER CATHETER; ELASTOMERIC PUMP

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

Patient Problem Foreign Body In Patient (2687)

Event Date 04/07/2014

Event Type  Injury  

Event Description

Drug/diluent: not applicable; fill volume: not applicable; flow rate: not applicable; procedure: unknown; cathplace: unknown.It was reported by a physician who contacted an i-flow sales representative that a catheter broke during removal.The incident happened on (b)(6) 2014.It was estimated about 7 cm of the catheter remnant was inside the patient.The catheter remnant would be left inside the patient unless the patient becomes symptomatic.Product and patient information are not available at this time.No sample will be returned and the removed catheter section was discarded.Attempts have been made (b)(4) 2014 to obtain additional information regarding the reported incident ((b)(4)).The physician reported that he will send in the information as soon as possible.

Manufacturer Narrative

Method: the catheter portion was reported to be discarded.A lot number was not provided therefore, a review of the device history record (dhr) cannot be conducted.Results: as no device was available for an evaluation no methods were performed, therefore results cannot be obtained.Conclusions: at this time the physician has decided not to remove the retrained portion of the catheter and the portion removed was discarded.Since an evaluation could not be conducted, we are unable to determine a cause for the reported event.Per the technical bulletin "tips for preventing in-situ catheter breakage with the on-q post-op pain relief system," recommendations are provided for removing the catheter: according to the directions for use "if resistance is encountered during removal, or if the catheter stretches, stop.It is advisable to wait 30-60 minutes and try again.The patient's body movements may relieve the catheter to allow easier removal.If the catheter is still difficult to remove, an x-ray is recommended.If additional information pertinent to this event becomes available, i-flow will submit a follow-up report.Information from this incident will be included in our product complaint and mdr trend reporting systems.Ongoing analysis of trend information is used to identify the need for additional investigations.

• Brand Name: SILVERSOAKER CATHETER
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): I-FLOW LLC,; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery, suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 3804586
• MDR Text Key: 4385216
• Report Number: 2026095-2014-00050
• 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: 04/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2014
• 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