MAUDE Adverse Event Report: CODMAN & SHURTLEFF CATHETER WITH TAPERED CONNECTOR; ARTERIAL CATHETER

Model Number	IP37957
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intera is aware that the tapered catheter is being used off-label with the medtronic pump for hepatic artery infusion.The surgical staff disposed of the catheter, so it was unavailable for physical evaluation.The lot used in the surgery was unknown.According to intera sales records, only two lots of catheters were sold to the reporter's institution, lot j32r96 and j58x05.The lot history records for both lots were reviewed and no nonconformances or deviations were noted in the records.No other reports of missing beads/rings have been reported to intera.For reference, the beads/rings are located at the end of the catheter.The surgeon may cut the end of the catheter when prepping for surgery and it may be possible to cut the beads/rings.Since no physical evaluation was able to be performed, it is undetermined if the catheter was cut in a manner that would have cut the bead.Since no other complaints have been reported and no product defect trend is detected, this complaint will be considered closed with no further corrective action.If additional complaint(s) are reported, corrective action will be considered.
Event or Problem Description
During a hepatic artery infusion implantation surgery, the surgeon reported that the tapered catheter was missing one of the three beads used to suture the catheter in place.The catheter was discarded and another catheter was used in place.There was no impact to the patient reported.

• Brand Name: CATHETER WITH TAPERED CONNECTOR
• Common Device Name: ARTERIAL CATHETER
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; rayhnam MA 02767
• MDR Report Key: 10681146
• Report Number: 3015537318-2020-00011
• Device Sequence Number: 3161588
• Product Code: LKK
• UDI-Device Identifier: 10886704044086
• UDI-Public: 10886704044086
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P890055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IP37957
• Device Catalogue Number: IP37957
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 10/14/2020
• 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: 47 YR
• Patient Weight: 85