MAUDE Adverse Event Report: CORDIS CORPORATION INTRO G 8F STR 95CM .035"; CATHETER, PERCUTANEOUS

Catalog Number	4038953S
Medical Device Problem Codes	Stretched (1601); Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, there was leakage from the vista brite tip intro g 8f str 95cm.035" side port.Additional information obtained from the product analysis states that elongation was observed from 80.5 cm to 83.5 cm from the hub.Additionally, a leak was found due to the crack present in the kink found at the juncture of the catheter body to the hub.There were no reported patient injuries.The product was stored, handled and prepped per the instructions for use (ifu).There was difficulty prepping the device because there was leakage from the side port.There was no damage noticed to the device prior to opening the package.There was no difficulty removing the device from the sterile packaging.The leakage was observed during prep.Another device was used to complete the procedure.The procedure was finished another device.One non-sterile unit of an intro g 8f str 95cm.035" catheter sheath introducer along with a vessel dilator was received for analysis inside a plastic bag.No original packaging was returned.Per visual analysis, the unit was observed kinked/twisted at the juncture of the body to the hub and kinked at 17.5 cm and at 31.5 cm from the hub.Also, it was observed elongated from 80.5 cm to 83.5 cm from the hub.No other anomalies were observed.A leak test was performed.A lab sample syringe filled with water was attached to the stopcock valve of the unit and pressure applied.A leak was observed coming out right from beneath the suture collar.Therefore, the suture collar was taken off from the unit and the catheter visually inspected once more.A crack could be observed in the previously mentioned kinked area at juncture of the catheter body to the hub.Therefore, a cross-section was performed on the hub to body of the unit in order to verify the body shaft to hub molding.The cross-section showed that the body shaft to hub was properly molded.Per microscopic analysis, the unit was inspected under fal vision system and presence of elongations observed on the catheter body shaft crack were found.Per dimensional analysis, the od and id of the unit were measured near to the kinked and elongated areas and the results were found within specification.A review of the manufacturing documentation associated with lot 17773399 was performed and it was found that no issues were noted that were considered potentially related to the reported complaint.The reported event as ¿cannula - cracked¿ as well as the reported event as ¿cannula - unraveled/stretched¿ were confirmed due to the cracked and elongated conditions of the unit as received.However, the exact cause of the cannula damage conditions could not be conclusively determined during the analysis.The cross-section performed on the hub area of the unit showed that the body shaft to hub was properly molded.Nonetheless, evidence of elongations on the body crack were shown.Elongation is a common characteristic of pieces which were pulled or stretched until rupture appears.Possible pulling and/or stretching events could have been related to the crack in the kinked/twisted unit at the juncture of the catheter body to hub.According to the product instructions for use, users are cautioned that if increased resistance is felt upon insertion or withdrawal of the csi, investigate the cause before continuing.If the cause of the resistance cannot be determined and corrected, discontinue the procedure and withdraw the csi.Neither the phr review analysis nor the product analysis results suggest that these damage conditions are related to the manufacturing process.Therefore, no corrective and preventive actions will be taken at this time.
Event or Problem Description
As reported, there was leakage from the vista brite tip intro g 8f str 95cm.035" side port.Additional information obtained from the product analysis states that elongation was observed from 80.5 cm to 83.5 cm from the hub.Additionally a leak was found due to the crack present in the kink found at the juncture of the catheter body to the hub.There were no reported patient injuries.The product was stored, handled and prepped per the instructions for use (ifu).There was difficulty prepping the device because there was leakage from the side port.There was no damage noticed to the device prior to opening the package.There was no difficulty removing the device from the sterile packaging.The leakage was observed during prep.Another device was used to complete the procedure.The procedure was finished another device.The device was returned for analysis.

• Brand Name: INTRO G 8F STR 95CM .035"
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 9145259
• Report Number: 9616099-2019-03247
• Device Sequence Number: 16851902
• Product Code: DQY
• UDI-Device Identifier: 20705032001004
• UDI-Public: 20705032001004
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K001136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/02/2019

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: 03/31/2021
• Device Catalogue Number: 4038953S
• Device Lot Number: 17773399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1