MAUDE Adverse Event Report: MEDCOMP 4FX50CM SGL PRO PICC CT-BASIC; PRO-PICC CT

Model Number MR17034101

Device Problem Knotted (1340)

Patient Problem Pain (1994)

Event Date 02/09/2018

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated.We are currently waiting for the sample to be returned for evaluation.When the investigation is complete a final report will be submitted.

Event Description

The vessel was smoothly punctured and the guidewire was introduced.There was a little bit of resistance.They tried to retract the guidewire in order to reposition the needle a little bit closer to the vessel, but the guidewire wouldn't retract.The needle was removed, but the guidewire was stuck in the subcutaneous fat tissue of the patient.A small incision was made in order to remove the knotted guidewire.

Manufacturer Narrative

Received a 0.018 guidewire for evaluation.A visual inspection revealed the guidewire to be kinked and bent at the tip.The device was forwarded to the device manufacturer for evaluation.Based on the investigation performed, it was determined that the product was made to specification.There were 7 sections along the guidewire where knotting might have occurred, however we are unable to determine the root cause of the event.Resistance met during insertion may be contributing factor.The instructions for use state "do not advance the guidewire or catheter if usual resistance is felt".

• Brand Name: 4FX50CM SGL PRO PICC CT-BASIC
• Type of Device: PRO-PICC CT
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7337240
• MDR Text Key: 102337296
• Report Number: 2518902-2018-00021
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00884908033069
• UDI-Public: 884908033069
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 08/28/2020
• Device Model Number: MR17034101
• Device Catalogue Number: MR17034101
• Device Lot Number: MJKM040
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Weight: 88