MAUDE Adverse Event Report: MEDCOMP 14F X 24CM DUO-FLOW 400XL CATHETER; HEMODIALYSIS CATHETER

Model Number DFXL149MT

Device Problems Material Fragmentation (1261); Sticking (1597)

Patient Problem Laceration(s) (1946)

Event Date 03/28/2015

Event Type  Injury  

Event Description

During the insertion procedure the guidewire was stuck within the patient and some force was applied in attempt to remove it.The guidewire snapped and broke into two pieces.The distal sharp end pierced through the physician's gloves and punctured the right index finger.The pieces were removed under fluoroscopy at the radiology department, the procedure was uneventful.

Manufacturer Narrative

The guidewire involved in the incident was not returned for evaluation due to the patient's health conditions.The complaint information and picture were forwarded to the manufacturer for review and evaluation.The supplied photograph of the specimen presents indications of an overload fracture of the proximal (straight) end of the core wire and subsequent stretching of the outer coil wraps exposing the distal aspect of the core wire fracture and a noticeable length of the exposed core wire distal to the fracture.No other damage or inconsistencies are noted to the specimen.A review of the device history record does not present any indications of manufacturing defect or anomaly that could have impacted on the event as reported.The history records indicate this product was final inspection tested and determined to be acceptable.Lot release testing yielded break, loads of between (b)(4) lbf (pounds force) well above the minimum requirement of (b)(4).Based on the evidence presented by the sample (photograph) and the information provided by the supporting documentation it appears that clinical and or procedural factors may have impacted on the event as reported.

• Brand Name: 14F X 24CM DUO-FLOW 400XL CATHETER
• Type of Device: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; harleysville PA
• Manufacturer (Section G): MEDCOMP; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: susan smith, rn ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 4758521
• MDR Text Key: 5796914
• Report Number: 2518902-2015-00049
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2015

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 Expiration Date: 01/31/2017
• Device Model Number: DFXL149MT
• Device Catalogue Number: DFXL149MT
• Device Lot Number: MGDC490
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/30/2015
• Initial Date FDA Received: 05/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2014
• 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): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 65