MAUDE Adverse Event Report: EPIMED INTERNATIONAL INC VERSA-KATH; CATHETER

Model Number	A-EP-042
Medical Device Problem Codes	Device Handling Problem (3265); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2019, (b)(6), managing director at (b)(6), emailed epimed regarding a sheared portion of catheter coating that was left within the patient at level c3.The doctor stated that he pulled the catheter to hard against the needle when attempting to reposition the catheter.The account stated that approximately 10 cm of the catheter coating was missing from the device.The reporting account provided epimed with pictures of the device after the reported event.Epimed conducted measurement analysis on the pictures and determined that none of the catheter's internal spring was missing from the device, and also confirmed that approximately 9-10 cm of the catheter coating was missing.The coating of the versa-kath catheter is fluorinated ethylene propylene (fep), and has been shown to be biocompatible in epimed's testing.No other information has been provided by the reporting account as of june 3, 2019.Epimed will continue to follow-up with the reporting account for a period of three months for any patient updates.
Event or Problem Description
On (b)(6) 2019, (b)(6), managing director at (b)(6), emailed epimed regarding a sheared portion of catheter coating that was left within the patient at level c3.The doctor stated that he pulled the catheter to hard against the needle when attempting to reposition the catheter.

• Brand Name: VERSA-KATH
• Common Device Name: CATHETER
• Manufacturer (Section D): EPIMED INTERNATIONAL INC; 141 sal landrio drive; johnstown NY 12095
• MDR Report Key: 8768957
• Report Number: 1316297-2019-00002
• Device Sequence Number: 1690240
• Product Code: BSO
• UDI-Device Identifier: 00818788021120
• UDI-Public: 00818788021120
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K023140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A-EP-042
• Device Catalogue Number: 156-2112
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 07/08/2019
• 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: Other