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

Model Number	MR17034102
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received a 4f sl pro-picc.Initial inspection showed a tear in the lumen.Device was sent to contract manufacturer for investigation.
Event or Problem Description
Lumen burst.
Additional Manufacturer Narrative
A review of the sample indicated there was no visible damage to the luer, extension, clamp, or hub.The lumen was trimmed short around the 42 cm mark from the hub.The lumen was ruptured between the 9cm and 10cm depth markings from the tip.When feeding a guidewire through the distal end of the sample, the lumen was fully obstructed around the 40 cm mark from the hub.Force was applied to the guidewire to allow for passage through the lumen.When the guidewire finally passed through the obstruction large fragments of red foreign material with the appearance of blood were noted exiting the lumen.Cross sections were prepared at 8 cm and 10 cm on both sides of the lumen rupture, as well as at 20 cm, 30 cm, and 40 cm to verify cross sectional dimensions.Dimensional requirements were satisfied for all prepared cross sections.We are unable to determine the cause of this event.There is no evidence of a manufacturing error.A contributing factor may include flushing or power injecting against an occluded lumen.The instructions for use contain the following warning.Failure to ensure patency of the catheter prior to power injection studies may result in catheter failure.

• Brand Name: 4FX50CM SGL PRO PICC CT-LONGGW
• Common Device Name: PRO-PICC CT
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8180680
• Report Number: 2518902-2018-00068
• Device Sequence Number: 2190329
• Product Code: LJS
• UDI-Device Identifier: 00884908033076
• UDI-Public: 884908033076
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K091953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

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?: No
• Operator of Device: Other
• Device Expiration Date: 07/03/2021
• Device Model Number: MR17034102
• Device Catalogue Number: MR17034102
• Device Lot Number: MLKN870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 06/13/2019
• 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: 54 YR
• Patient Weight: 70