MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CARDIAC CATH PACK (CCHKE)819; ANGIOGRAPHY/ANGIOPLASTY KIT

Model Number	SAN41CCHKE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the investigation, from the device history record, lot# 20191101-23-sh was finished on 04th nov 2019.No exception was recorded in the device history record that could lead to the reported incident.The average linting data is (b)(4).There are 164 occurrences reported in the past 12 months.No sample returned for investigation, only photos were provided.From the photos there is a nep seen on the surface of the towel.According to supplier, the or towel is made of cotton, so cotton fiber is born.Supplier is continuously working with cardinal health to better control the linting and have implemented several measures to improve it: suctions machines have been installed in grey cloth rolling process, dyeing process, and cutting process the suction process was added before product's final folding, and workers do it according to standard operation procedure requirement.Linting test method and acceptable criteria was stipulated to see the suction results.(b)(4).In the folding process, supplier used one cloth pad under 100 pieces semi-finished products to avoid linting stuck onto the products during product's transfer.From the investigation, there is no abnormal situation happened in production or dhr.Therefore, the root cause could not be determined.The complaint information was informed to the relevant sectors for their awareness.There is no action taken at this time, but supplier will continue to monitor the trend of this type of incident.
Event or Problem Description
Customer reported lint and fuzz coming from the sterile towels pwtb04-stm from the cardiac catheterization pack san41cchke during a peripheral intervention.Lint was found on the wires and balloons during the procedure.Pieces were removed with irrigation and manual removal.No injury occurred.No patient demographics were provided upon request.

• Brand Name: CARDIAC CATH PACK (CCHKE)819
• Common Device Name: ANGIOGRAPHY/ANGIOPLASTY 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: 10962620
• Report Number: 1423537-2020-00573
• Device Sequence Number: 14261420
• Product Code: OEQ
• UDI-Device Identifier: 10887488627731
• UDI-Public: 10887488627731
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 12/07/2020

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: SAN41CCHKE
• Device Catalogue Number: SAN41CCHKE
• Device Lot Number: 488522
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 12/07/2020
• 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