MAUDE Adverse Event Report: CORDIS CORPORATION GC 9F .098 STR 55CM; CATHETER, PERCUTANEOUS

Model Number 598943P

Device Problems Device Contamination with Chemical or Other Material (2944); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17814511 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, particulate found in sterile pouch.Some loose.Some still attached.The devices will be returned for analysis.The integrity of the sterile pouch was not compromised.The actual product was not damaged.There was no damage to the outer product box.

Manufacturer Narrative

This medwatch report reflects (b)(4) products with the same catalog and lot number.This correction is being sent to reflect the correct quantity of products involved.

Event Description

As reported, particulate found in sterile pouch.Some loose.Some still attached.The integrity of the sterile pouch was not compromised.The actual product was not damaged.There was no damage to the outer product box.(b)(4) devices were affected.(b)(4) devices from lot number 17814511 and (b)(4) devices from lot number 17811028.The (b)(4) devices will be returned for analysis.

Manufacturer Narrative

As reported, particulate was found in the sterile pouch of 56 gc 9f.098 str 55cm catheters.Some of this material was loose and some was still attached to the mounting card.The integrity of the sterile pouches was not compromised.The actual devices were not damaged.There was no damage to the outer packaging.The devices were not used in patient procedures.No other information was reported.2018-00052303-1 eighteen devices were returned for analysis.Eighteen sterile units, corresponding to cat.No.598943p, (gc 9f.098 str 55cm) lot no.17814511, were received for analysis.Per visual analysis, all the angel hair/slivers detected were adhered to the tabs of the mounting cards except some pieces in which a loose angel air/sliver was detected after removing the device from the packaging, however, angel hair/slivers can be loosened by excessive handling of the devices.Based on the shape and location where the angel hair/slivers were detected the root cause of this failure can be attributed to the tab cutting process during the mounting card manufacturing process.No particle adhered to the catheter was detected (internally or externally) during all the inspections performed.A review of the manufacturing documentation associated with lot 17814511 was performed and a risk assessment has been opened to further investigate this issue.2018-00052303-2 thirty-eight devices were returned for analysis.Thirty-eight sterile units, corresponding to cat.No.598943p, (gc 9f.098 str 55cm) lot no.17811028, were received for analysis.Per visual analysis, all the angel hair/slivers detected were adhered to the tabs of the mounting cards except some pieces in which a loose angel air/sliver was detected after removing the device from the packaging, however, angel hair/slivers can be loosened by excessive handling of the devices.Based on the shape and location where the angel hair/slivers were detected the root cause of this failure can be attributed to the tab cutting process during the mounting card manufacturing process.No particle adhered to the catheter was detected (internally or externally) during all the inspections performed.A review of the manufacturing documentation associated with lot 17811028 was performed and a risk assessment has been opened to further investigate this issue.The event reported by the customer as ¿packaging/pouch/box-pinsc - foreign material - in sterile package¿ was confirmed since per visual analysis presence of angel hair/slivers in the sterile packages received was confirmed.This material is part of the mounting card material and was not cleanly cut.The inner pouches were fully reviewed, and no loose pieces of cardboard were found.According to the safety information in the instructions for use ¿inspect the guiding catheter before use to verify that its size, shape and condition are suitable for the specific procedure.¿ the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, a corrective/preventive action will be taken at this time.

Manufacturer Narrative

Recall number: z-1198-2019.

• Brand Name: GC 9F .098 STR 55CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8219079
• MDR Text Key: 132229300
• Report Number: 9616099-2019-02619
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K925131
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 598943P
• Device Catalogue Number: 598943P
• Device Lot Number: 17814511
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1