MAUDE Adverse Event Report: RHYTHMLINK INTERNATIONAL LLC PROPEP PEP ELECTRODE KIT; RLSP370

Model Number RLSP370

Device Problems Detachment Of Device Component (1104); Retraction Problem (1536); Difficult to Advance (2920); Difficult to Open or Remove Packaging Material (2922)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/11/2016

Event Type  malfunction  

Manufacturer Narrative

The failing device was discarded and not returned to the manufacturer.The manufacturer did not have any additional devices in stock or in retains with lot number 00003770.Incoming inspection for all raw materials used in the production lot showed no abnormalities or raw material failures.Production of this device used standard raw materials and processes.No production abnormalities were noted.No shipment or storage abnormalities were noted for this production lot.No other customer complaints, issues or failures were associated with this production lot.Manufacturer attempted to duplicate the failure modes in the engineering lab using the same product but different lot numbers.The manufacturer could not duplicate or determine what caused the product to be difficult to remove from the packaging.As far as the introducer needle separating from its handle, we were unable to duplicate that failure on similar product.However, we believe the most likely cause to be a failure of the glue joint between the cannula needle and its holder.The manufacturer could find no defect in the process or materials but will continue investigation by observation of product currently being manufactured.Manufacturer data entered by (b)(6).On (b)(6) 2016.Not returned to manufacturer.

Event Description

When removing the introducer from the packaging it was hard to remove.Then when advancing the introducer into the patient it was hard to advance.When trying to retract it was also very hard, almost like the locking mechanism was not completely disengaging.When removing it the needle broke off in the patient.The needle was removed from the patient and it was verified that the needle was completely removed.Since the surgical assistant is the one that removed it from the tray, the clinician/reporter could not really say if it were glued into the tray or just "tight" in the tray.The clinician/reporter did inspect the tray afterward and did not see any glue spots in it.The mechanism contains two "needles", a cannula which is used to "introduce" the needle electrodes into the abdomen (called the introducer), and needle electrode "wires" (called electrodes).The part that broke off into the patient is in reference to the introducer needle, not the electrode.After the introducer needle was extracted from the patient, the surgical assistant placed it back in place on the introducer mechanism to make sure it matched up exactly and there were no parts inadvertently left in the patient.The assistant said it matched up exactly, leading the clinician/reporter to believe it likely came unglued rather than the needle shaft itself breaking.

• Brand Name: PROPEP PEP ELECTRODE KIT
• Type of Device: RLSP370
• Manufacturer (Section D): RHYTHMLINK INTERNATIONAL LLC; 1140 first street south; columbia SC 29209
• Manufacturer (Section G): RHYTHMLINK INTERNATIONAL LLC; 1140 1st st south; columbia SC 29209
• Manufacturer Contact: gerald keisler ; 1140 1st st south; columbia, SC 29209 ; 8032521222
• MDR Report Key: 6166235
• MDR Text Key: 62613581
• Report Number: 1067162-2016-00002
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103200
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/02/2016

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 Expiration Date: 08/30/2016
• Device Model Number: RLSP370
• Device Catalogue Number: RLSP370
• Device Lot Number: 00003770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2016
• Initial Date FDA Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2014
• 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