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

Catalog Number 598943P

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17807995 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.

Event Description

As reported, a particulate was found in sterile pouch.A picture has been sent.The integrity of the sterile pouch was not compromised.The actual product was not damaged.There was no damage to the outer product box.The devices will be returned for analysis.

Manufacturer Narrative

Recall number: z-1198-2019.

Manufacturer Narrative

The customer complained of particles being inside sterile field of packaging of multiple 9f.098 str 55cm guide catheters.The integrity of the sterile pouch was not compromised.The actual product was not damaged.The devices were not used in a patient.There was no damage to the outer product box.No other information was reported.The devices were returned for analysis.212 sterile units, corresponding to cat.No.598943p, (gc 9f.098 str 55cm) lot no.17807995, were received for analysis.Particles (angel hair/slivers) were noted in the sterile packaging and remained attached to the mounting card tabs.A review of the manufacturing documentation associated with lot 17807995 was performed and a risk assessment has been opened to further investigate this issue.The event reported by the customer as ¿packaging/pouch/box - foreign material - in sterile package¿ was confirmed, due to frays of cardboard (angel hair/slivers) attached to the mounting cards tabs, as well as loose angel hair/slivers being detected after removing the device from the packaging, being confirmed.This material is part of the mounting card material and were not cleanly cut.The inner pouches were fully reviewed.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

Please note that this medwatch report reflects 212 products with the same catalog and lot number.This correction is being sent to reflect the correct quantity of products involved.

Event Description

Particulate found in sterile pouch.A picture has been sent.The integrity of the sterile pouch was not compromised.The actual product was not damaged.There was no damage to the outer product box.212 devices were affected.The devices will be returned for analysis.

• 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: 8174941
• MDR Text Key: 131796489
• Report Number: 9616099-2018-02593
• 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: 12/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 598943P
• Device Lot Number: 17807995
• 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