MAUDE Adverse Event Report: CORDIS CORPORATION 10F-STR 80CM; CATHETER, PERCUTANEOUS

Model Number	511040P
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, an unknown optease was unable to be retracted to a 10f straight vista brite tip guiding catheter.Therefore, an unknown snare was pushed to change the position of catch, but the vista brite tip catheter and the unknown optease did not released.The physician retracted the unknown snare by pushing the vista brite tip catheter.To remove the optease, the physician damaged the distal tip as intend.The distal tip released, and the tip was caught on the unknown snare and the devices were removed together.The optease was successfully removed during the procedure.There was no reported patient injury.The physician guesses that the unknown optease hook bite into the guiding tip and was caught, so it may not have been pulled in.The product was stored, handled, and prepped properly according to the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.The device was not kink or bend at any time.The device will be returned for evaluation.Addendum: during visual analysis of the device, the brite tip of the straight vista was observed ripped off from the unit, caught among the optease and the snare device.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18079983 presented no issues during the manufacturing process that can be related to the reported event.Complaint conclusion : as reported, an unknown optease was unable to be retracted to a 10f straight vista brite tip guiding catheter.Therefore, an unknown snare was pushed to change the position of catch, but the vista brite tip catheter and the unknown optease did not released.The physician retracted the unknown snare by pushing the vista brite tip catheter.To remove the optease, the physician damaged the distal tip as intend.The distal tip released, and the tip was caught on the unknown snare and the devices were removed together.The optease was successfully removed during the procedure.There was no reported patient injury.The physician guesses that the unknown optease hook bite into the guiding tip and was caught, so it may not have been pulled in.The product was stored, handled, and prepped properly according to the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.The device was not kink or bend at any time.Addendum: during visual analysis of the device, the brite tip of the straight vista was observed ripped off from the unit, caught among the optease and the snare device.The device was returned for evaluation.One non-sterile 10f straight vista brite tip guiding catheter, an unknown optease and an unknown snare, inside a plastic bad, were received for analysis.Per visual analysis, the brite tip of the straight vista was observed ripped off from the unit, caught among the optease and the snare device.No other anomalies found.Per microscopic analysis, the tip to brite tip area of the unit from which the brite tip was ripped off was inspected under the vision system and evidence of material elongations were observed.Elongations are commonly associated with separations caused by material tensile overload.Also, per microscopic analysis, the 10f straight vista brite tip guiding catheter was sent to sem analysis to determine the root cause of the separated condition.Sem results showed that the surface characteristics showed striation patterns observed in the separation section, commonly associated with polymeric elongation due to excessive stress.No other anomalies were observed during sem analysis.Per dimensional analysis, the outer diameter (od) and the inner diameter (id) of the unit were measured near the separated area and were found within specification.A product history record (phr) review of lot 18079983 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿brite tip/distal tip ¿ separated - in-patient¿ was confirmed during analysis of the returned device.While the exact cause for the event could not conclusively be determined there are procedural and device interaction factors, as described in the complaint, that may have contributed to the event.According to the instructions for use (ifu), although not intended as a mitigation of risk, if strong resistance is met during manipulation, discontinue the procedure and determine the cause of the resistance before proceeding.If the cause of the resistance can not be determined, withdraw the catheter.Torquing the guiding catheter excessively while kinked may cause damage which could result in possible separation along the catheter shaft.Should the guiding catheter shaft become severely kinked, withdraw the entire system (guiding catheter, guidewire and catheter sheath introducer).Advancement, manipulation and withdrawal of the guiding catheter should always be performed under fluoroscopic guidance.Based on the information available and the phr review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: 10F-STR 80CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15534013
• Report Number: 9616099-2022-06039
• Device Sequence Number: 12724811
• Product Code: DQY
• UDI-Device Identifier: 20705032010495
• UDI-Public: (01)20705032010495(17)241231(10)18079983
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K971572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/03/2022

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 Expiration Date: 12/31/2024
• Device Model Number: 511040P
• Device Catalogue Number: 511040P
• Device Lot Number: 18079983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN OPTEASE; UNKNOWN SNARE
• Patient Sex: Unknown