MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE EPILONG SOFT; CATHETER, ANAESTHESIA CONDUCTION, EPIDURAL, CONTINUOUS

Model Number	0431157-51
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event took place in (b)(6) and has been reported through distribution subsidiary pajunk medical produkte gmbh.Currently the data is poor and the device has not been returned/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.
Event or Problem Description
(b)(4).Tentative summarizing translation from initial reporter´s narrative: pt underwent uneventful ivor lewis minimal invasive esophagectomy.Analgesia was administered through a thoracoscopic placed paravertebral catheter placed by the surgeon during the operation, with good effect.After removal of catheter, 5 days post operation, the nurse noticed the end of the catheter was destructed.
Additional Manufacturer Narrative
Based on risk assessment and clinical evaluation report as well as substantiated by post market data this case is considered as closed.
Event or Problem Description
Irn#: (b)(4).Tentative summarizing translation from initial reporter´s narrative: pt underwent uneventful ivor lewis minimal invasive esophagectomy.Analgesia was administered through a thoracoscopic placed paravertebral catheter placed by the surgeon during the operation, with good effect.After removal of catheter, 5 days post operation, the nurse noticed the end of the catheter was destructed.

• Brand Name: EPILONG SOFT
• Common Device Name: CATHETER, ANAESTHESIA CONDUCTION, EPIDURAL, CONTINUOUS
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 8415334
• Report Number: 9611612-2019-00006
• Device Sequence Number: 11224199
• Product Code: CAZ
• UDI-Device Identifier: 14048223013134
• UDI-Public: 14048223013134
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K060311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2019

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: Health Professional
• Device Expiration Date: 05/28/2023
• Device Model Number: 0431157-51
• Device Catalogue Number: 0431157-51
• Device Lot Number: 1256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 04/11/2019
• 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