MAUDE Adverse Event Report: CORDIS CORPORATION AVANTI + 5F STD W/GW; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Catalog Number 504605X

Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).As reported, an avanti + 5f std w/gw sheath was opened and had a black dot on the top, therefore it was not used.There was no reported patient injury.The reported foreign material was on the actual sheath where the guide wire would be introduced.Black specs were observed on the actual sheath hub when it was opened.The integrity of the sterile pouch was not compromised.The foreign material was noted when the sheath was opened from the sterile package.The sheath was stored in a 5 pack box in the lab.The actual product was contaminated.The associate observed the sheath was contaminated and was removed from the field and placed in specimen bag.A second avanti + 5f std w/gw sheath would not advance into the sheath, therefore a new sheath was utilized.The products were stored and handled according to the instructions for use (ifu).The product was properly flushed and inspected prior to use.The sheath was not kinked or bent during prep or during insertion.The sheath was never used on the patient.(b)(4).Two non-sterile units of avanti + 5f std w/gw cannula sheaths along with two vessel dilators were received for analysis inside a plastic bag.The plastic bag was received labeled as case (b)(4).No original tray/packaging was received.Per event description, the received units were numbered/ identified as units one and unit two to perform the analyses.The unit under case (b)(4) corresponds to complaint code: ¿packaging/pouch/box-foreign material - in sterile package¿ while the unit under case (b)(4) corresponds to complaint code: ¿catheter sheath introducer (csi)-obstructed.¿ per visual analysis of this present case (b)(4), a tiny blackish loose foreign material could be observed on top of the gasket on the hub of unit.No other anomaly was found either on the cannula sheath or in its accompanying vessel dilator.The loose foreign material was taken off from the hub and visually inspected under vision system.Under vision system, the foreign material looked irregular in shape and kind of plastic in external appearance.However, the foreign material could not be identified.The foreign material received on the complaint unit was submitted to qa analytical laboratory to perform ft-ir analysis to identify its chemical composition.In addition, a control bts sample was also submitted to qa analytical laboratory to compare it with the black foreign material received in order to confirm or discard the likeness of the foreign material found to the bts as no other material but the bts is the unique black material used to build the csi products at the manufacturing line.Per analytical laboratory analysis report, it was concluded that the foreign black material showed a nitrile rubber chemical composition.However, it is not the same as the bts control sample composition based on the spectrum obtained and peaks observed.A review of the manufacturing documentation associated with lot 17627985 was performed and no units were rejected during the final assembly of this lot.No other issues were noted that were considered potentially related to the reported complaint.The reported event by the customer as ¿packaging/pouch/box-foreign material - in sterile package¿ was confirmed due to the tiny blackish loose foreign material observed on top of the gasket on the hub of unit as received.The original (sterile/ sealed) packaging was not received for evaluation and the analyzed foreign matter was not found to be used during the catheter sheath introducer manufacturing process.The exact cause of the foreign material found on the unit could not be conclusively determined.According to the product instruction for use, users should not use the product if it is opened or damaged as was done in this case.Neither the product analysis nor the device history record review suggest that the reported event is related to the manufacturing process.Therefore, no corrective or preventative actions will be taken at this time.(b)(4).Per visual analysis of this present case (b)(4), the vessel dilator was received fully inserted through the cannula sheath.No original packaging was returned for analysis.Neither anomaly was found either on the mini guide wire or on the cannula sheath.However, the vessel dilator was found kinked right at the juncture of the hub.No other anomalies observed.The cannula sheath and vessel dilator od and id were measured and results were found within specification.Functional analysis was performed on the non-sterile vessel dilator received.A lab sample syringe filled with water was attached to the stopcock of cannula sheath and onto the hub of vessel dilator and successfully flushed.Neither resistance nor loosen material/matter was observed during flushing procedure.Then, as indicated, a.035¿ lab sample mini guide wire was introduced into the vessel dilator despite the kinked at juncture of hub condition as received.Also, the vessel dilator was successfully introduced into cannula sheath.Slight resistance was felt during mini guide wire insertion through vessel dilator due to the kink found.However, neither resistance was felt nor experienced during vessel insertion into the cannula.A review of the manufacturing documentation associated with this lot was performed and no units were rejected during the final assembly of this lot.No other issues were noted that were considered potentially related to the reported complaint.The complaint reported by the customer as ¿catheter sheath introducer (csi)-obstructed¿ was not confirmed during the analysis since functional and dimensional analyses were successfully performed on the received unit.However, a kink condition at the juncture of the hub was observed.Nonetheless, the cause of the kinked condition found on the vessel dilator could not be conclusively determined during the analysis.Neither the product analysis nor the device history record review results suggest that the reported event is related to the manufacturing process.Therefore, no corrective or preventative actions will be taken at this time.

Event Description

As reported, an avanti + 5f std w/gw sheath was opened and had a black dot on the top therefore it was not used.The reported foreign material was on the actual sheath where the guide wire would be introduced.Black specs were observed on the actual sheath hub when it was opened. the integrity of the sterile pouch was not compromised.The foreign material was noted when the sheath was opened from sterile package.The sheath was stored in a 5 pack box in the lab. the actual product was contaminated.The associate observed the sheath was contaminated and was removed from the field and placed in specimen bag. a second avanti + 5f std w/gw sheath,.035 guidewire would not advance into the sheath, therefore a new sheath was utilized.  the products were stored and handled according to the instructions for use (ifu).  the product was properly flushed and inspected prior to use.The sheath was not kinked or bent during prep or during insertion.The sheath was never used on the patient.There was no reported patient injury.The products will be returned for analysis.

• Brand Name: AVANTI + 5F STD W/GW
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6763044
• MDR Text Key: 81735351
• Report Number: 9616099-2017-01287
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 504605X
• Device Lot Number: 17627985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening