MAUDE Adverse Event Report: MARVAO MEDICAL NEXSITE HD STEPPED TIP; HEMODIALYSIS CATHETER

Catalog Number	NEXHD1552801
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation because the device remains implanted; therefore an analysis of the complaint device could not be completed.A review of the manufacturing documentation confirmed that the lot met the specification requirements.Taking into consideration the evaluation conducted and the details of the complaint, this investigation was assigned the most probable root cause of "caused by other".The complaint investigation indicates another device/drug/procedure/illness/co-morbidity caused the complaint event.Per the study site, the traction from the shirt pulling on the catheter could definitely explain why it was bleeding again after the successful placement.
Event or Problem Description
Study (b)(6): the nexsite device was successfully placed on (b)(6) 2016.Subject was given standard post procedure care instructions which include to seek immediate medical attention should excessive bleeding occur.Later that day (about 5 hours after procedure), the subject attended the emergency department.The ed resident mentions that the subject told them that the catheter "tugged shirt and since then has been slowly bleeding".The nephrologist recommended overnight observation stay with dialysis planned for the morning.Nephrologist noted the permcath site looked ok and placement was confirmed on x-ray.Consultation note mentioned subcutaneous bleeding into tunnel tract.Subject was given empiric dose of ancef 2 grams with hemodialysis treatment.No fever was noted and no other signs/symptoms of infection mentioned.Subject's bleeding was controlled with vitamin k, desmopressin, local compression and ice packs.The subject was discharged in a satisfactory condition.The event had resolved on (b)(6) 2016.The traction from the shirt pulling on the catheter could definitely explain why it was bleeding again after the successful placement.No subject would have been discharged after the procedure with active bleeding.The traction could have slightly dislodged any clotting attempts and resulted in new bleeding.

• Brand Name: NEXSITE HD STEPPED TIP
• Common Device Name: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MARVAO MEDICAL; innovation in business centre; gmit, dublin road; galway, H91 D CH9; EI H91 DCH9
• MDR Report Key: 6236070
• Report Number: 3008110587-2016-00046
• Device Sequence Number: 19089149
• Product Code: MSD
• UDI-Device Identifier: 05391525640020
• UDI-Public: (01)05391525640020(17)170401(10)43967
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K121933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2016

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: Physician
• Device Catalogue Number: NEXHD1552801
• Device Lot Number: 43967
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2016
• Initial Report FDA Received Date: 01/10/2017
• 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: 53 YR
• Patient Weight: 64