MAUDE Adverse Event Report: CORDIS CORPORATION VISTA BRITE TIP GUIDING CATHETERS; CARDIOLOGY GUIDING CATHETERS (DQY)

Catalog Number 67005400

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was returned for analysis, however the engineering evaluation has not yet been completed.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information will be submitted within 30 days of receipt.

Event Description

It was reported that there was a brownish foreign matter located inside of the sterile pouch of a 6f 0.070 xb 3.5 vista brite tip guiding catheter during an incoming visual check process at (b)(4).The outer product box and sterile pouch were intact, and the seal of the pouch was not opened.The brownish foreign matter appeared to be a moveable particle.The actual product had no damage.There were no anomalies noted except for this failure.The product was already in this condition when it was delivered.The product was handled and stored as per usual procedure.It was not shipped out of the jj warehouse and was not clinically used.The product was neither re-sterilized nor re-packaged.The product will be returned for analysis.

Manufacturer Narrative

Product analysis: one sterile unit of 6f.070 xb 3.5 100cm was received in the sterile packaging.The box was opened and pouch was closed.The product was at the correct position.Foreign material was found inside the pouch.No other damages were noted.The foreign material was measured it was found within specification.A review of the manufacturing documentation associated with this lot was performed and the following was found: a device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.The reported failure ¿foreign material¿ was confirmed.The root cause could not be conclusively determined it.However during dimensional analysis, the foreign material was measured it was found within specification.Controls are in placed at the assembly processes to detect this kind of issue ppe wi 7500781 rev.99.Therefore no actions will be taken.The product was returned and engineering evaluation completed.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Complaint conclusion: as reported, when the physician placed the 0.035in terumo guidewire into the 5f 110cm infiniti pigtail catheter, some ¿jelly product¿ drained out of the catheter prior to use on the patient.There was no report of patient injury.The device was stored, handled, and prepped according to the instructions for use (ifu).There were no anomalies or other damages noted to the device or packaging.The ¿jelly product¿ appeared to be some type of ointment or vaseline.There was no peeling noted in the inner or outer catheter.The jelly product was also noted in the other two catheters involved.One sterile unit of 6f.070 xb 3.5 100cm was received in the sterile packaging.The box was opened and pouch was closed.The product was at the correct position.Foreign material was found inside the pouch.No other damages were noted.The foreign material was measured and was found within specification.The unit was sent to ftir analysis in order to analyze the foreign material found.Ftir technique was applied for the identification of a foreign material associated to the cordis customer complaint (b)(4).Ir data revealed that material is primarily composed of a silicon-based material.Additionally, the presence of a second compound primarily composed of alcohol or phenols due to the presence of hydroxyls within the material formulation was identified.Although it is not possible to determine precisely what is the exact compound conforming the foreign material submitted for analysis, the ir data demonstrated that the core component of the material is a silicon-based material; therefore, the investigation can be routed to evaluate compounds containing silicon within its formulation.Review of lot 17268353 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The reported event ¿foreign material¿ was confirmed due to the presence of a foreign material upon inspection.The root cause of the event reported by the customer could not be conclusively determined during the analysis.The ftir analysis was unable to determine if the foreign material found (silicon-based material) was related to the manufacturing process.In addition, during dimensional analysis, the foreign material was measured and found to be within specification.Controls are in place at the assembly processes to detect this kind of issue.Based on the product analysis and the device history record 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: VISTA BRITE TIP GUIDING CATHETERS
• Type of Device: CARDIOLOGY GUIDING CATHETERS (DQY)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5006352
• MDR Text Key: 23128995
• Report Number: 9616099-2015-00366
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K021593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: 67005400
• Device Lot Number: 17268353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1