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U.S. Department of Health and Human Services

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

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RHYTHMLINK INTERNATIONAL LLC PROPEP PEP ELECTRODE KIT RLSP370 Back to Search Results
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.
 
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Brand NamePROPEP PEP ELECTRODE KIT
Type of DeviceRLSP370
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 Key6166235
MDR Text Key62613581
Report Number1067162-2016-00002
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103200
Number of Events Reported1
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
Date FDA Received12/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/30/2016
Device Model NumberRLSP370
Device Catalogue NumberRLSP370
Device Lot Number00003770
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/11/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/30/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/12/2016 Patient Sequence Number: 1
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