MAUDE Adverse Event Report: MEDCOMP 5FX55CM DUAL PRO-PICC; PRO-PICC CT

Model Number	MR17035206MB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was forwarded to the contract manufacturer for evaluation.
Event or Problem Description
Tip of wire came apart in patient.
Additional Manufacturer Narrative
The device history recorded revealed the device to be made to specifications with no deficiencies or non conformities noted.The sample analysis showed the wire experienced tensile force beyond the design capabilities.Per the incident report during the insertion of the picc line resistance was met with removal of guidewire.A root cause could not be determined, but a contributing factor could have been the user pulling against resistance causing significant wire damage and resulting in device separation.The ifu states -" do not insert or withdraw the guidewire forcibly from any component.The wire may break or unravel.If the guidewire becomes damaged, the introducer needle or sheath dilator and guidewire must be removed together.The risk analysis was reviewed and this failure mode is covered.

• Brand Name: 5FX55CM DUAL PRO-PICC
• Common Device Name: PRO-PICC CT
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 6692361
• Report Number: 2518902-2017-00033
• Device Sequence Number: 10976534
• Product Code: LJS
• UDI-Device Identifier: 00884908083392
• UDI-Public: 884908083392
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2018

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/31/2018
• Device Model Number: MR17035206MB
• Device Catalogue Number: MR17035206MB
• Device Lot Number: MCCW770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Initial Date Received by Manufacturer: 06/08/2017
• Supplement Date Received by Manufacturer: 06/08/2017
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 05/17/2018
• 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