MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CARDIAC CATH PACK 7709 255; GENERAL SURGERY TRAY (KIT)

Model Number	SANHFCCFTB
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint and sample were forwarded to the manufacturing facility and it is currently under investigation.A follow-up report will be filed once investigation is completed.
Event or Problem Description
The customer reported that during a percutaneous coronary intervention, the doctor could not advance any balloons or stents over the angioplasty wire after multiple attempts.The tech recommended changing wires.When the wire was removed, the team saw a large piece of lint on the angioplasty wire.The surmised that it came from the femoral drape 29570na from the cardiac catheter kit/sanhfccftb.They also found a large amount of lint on their gloves and in the sterile heparin saline flush bowl.They reported there was no patient injury.No patient demographics were provided when asked.
Additional Manufacturer Narrative
Mdr follow-up report being filed as investigation results available a review of the device history record for the femoral angiography drape involved in the reported incident used in the cardinal health cardiac catheter pack, catalog number sanhfccftb, could not be reviewed as a lot number was not provided and the sample was not received for evaluation.A historical review of complaints for this device was conducted from 01-01-2017 to 02-12-2019 for product 29570na, lot # 2028bh1 and the review indicated this was an isolated incident.Based on the limited information available at this time and no product sample provided, the root cause could not be determined.We concluded this issue could occur due to an incorrect handling of the product after the lamination process or during the cutting or packing process.The following actions were taken in order to prevent this type of issue: corrective action: employee awareness documented training was provided to the those involved in the process of this product.Our cleaning activities will be reinforced in order to reduce or eliminate any kind of contamination that could be affect our product.If a sample is provided at a later date, the investigation will be re-opened, and an addendum report will be provided.We will continue monitoring our customer complaints data base for this and any other issues reported of the same nature in this catalog.

• Brand Name: CARDIAC CATH PACK 7709 255
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• MDR Report Key: 8384777
• Report Number: 1423537-2019-00279
• Device Sequence Number: 11519715
• Product Code: LRO
• UDI-Device Identifier: 10888439231755
• UDI-Public: 10888439231755
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2019

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 Model Number: SANHFCCFTB
• Device Catalogue Number: SANHFCCFTB
• Device Lot Number: NONE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 03/02/2019
• Supplement Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other