MAUDE Adverse Event Report: MEDCOMP 6FX60CM DL PROLINE CT; PRO-LINE CT

Model Number	MR28036221
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.When the investigation is complete a final report will be filed.
Event or Problem Description
Defect (weakening of the catheter wall causing a balloon).Incidental finding on a chest x-ray.
Additional Manufacturer Narrative
Received one 6f double lumen pro-line for evaluation.The extensions were cut several inches above the hub to remove the luers and the lumen was trimmed short around the 14 cm mark.The lumen was ballooned and burst between the 9-10 cm depth markings.The burst area only impacted one of the two lumens.A guidewire test and cross sections of the lumen indicated that both lumens were obstructed.Flushing against resistance may have caused the lumen to balloon and burst.

• Brand Name: 6FX60CM DL PROLINE CT
• Common Device Name: PRO-LINE CT
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7578773
• Report Number: 2518902-2018-00035
• Device Sequence Number: 16735423
• Product Code: LJS
• UDI-Device Identifier: 00884908094275
• UDI-Public: 884908094275
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2019

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
• Operator of Device: Other
• Device Expiration Date: 09/27/2020
• Device Model Number: MR28036221
• Device Catalogue Number: MR28036221
• Device Lot Number: MJKY890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 05/15/2019
• 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: 4 YR