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

Model Number	MR17034101
Medical Device Problem Code	Knotted (1340)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/09/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: PRO-PICC CT
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7337240
• Report Number: 2518902-2018-00021
• Device Sequence Number: 1095013
• Product Code: LJS
• UDI-Device Identifier: 00884908033069
• UDI-Public: 884908033069
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2018

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2018
• Supplement Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 03/14/2018
• Supplement Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR
• Patient Weight: 88