MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG CURL SONO; PERIPHERAL ANAESTHESIA CONDUCTION CATHETER

Model Number	521188-34C
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on risk assessment and clinical evaluation file is considered as closed.
Event or Problem Description
(b)(4).From initial reporter: (b)(6) clinic was given to a patient rectus sheet block on both sides after a gynecological surgery for pain management on (b)(6) 2017 with pajunk sonolong curl echo catheters purchased from mediq (b)(4).The procedure went smoothly.On (b)(6) 2017 catheters were removed from the upper abdomen.The nurse removed the second catheter without any problems, but in another catheter there seemed to be a resistance.When pulling the catheter, it really felt a resistance and mild pain in the upper abdomen, and pulling the catheter continued until the white catheter came out of the skin.From the inside of the catheter appeared a frustrated metal wire-like line that stretched and stretched until it broke.There was apparently the catheter's head in the patient because the black point on the tip was missing from the out coming catheter.There was also left an unknown number of steel helical coil in the patient.It was suspected that the catheter's head would have gone into node because the injection site was such that the catheter would not be able to stick to any structure.

• Brand Name: SONOLONG CURL SONO
• Common Device Name: PERIPHERAL ANAESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7163625
• Report Number: 9611612-2018-00005
• Device Sequence Number: 13919151
• Product Code: CAZ
• UDI-Device Identifier: 14048223020385
• UDI-Public: 14048223020385
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K113188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/04/2017

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: Nurse
• Device Model Number: 521188-34C
• Device Catalogue Number: 521188-34C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 01/04/2018
• 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