MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CUSTOM ANGIO PACK 629; ANGIOGRAPHY/ANGIOPLASTY KIT

Model Number	SAN44CAUTA
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
From the device history record, lot# 20200218-23-sh was manufactured on 17th jan 2020.Based on supplier investigation, device history record review did not indicate any exception that could lead to the reported incident.The average linting data is 0.145g / 10 pieces.There is 145 similar occurrence reported in the past 12 months.No sample was available at the time of the investigation, only photo was provided with blue lint.According to supplier, 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.(=0.38g/10 pieces).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, no abnormal situation happened in production.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 that the blue, sterile, cotton or towels pwtb04-stm from the custom angio pack san44cauta are shedding fibers onto various wires and catheters during a left vertebral artery angioplasty and stenting.The towels were used for fluid absorption outside the drape.There was a 30- minute delay, with no injury or adverse effect to the patient.No patient demographics were provided.Cardinal health is proactively filing a report for malfunction.

• Brand Name: CUSTOM ANGIO PACK 629
• 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: 10094208
• Report Number: 1423537-2020-00461
• Device Sequence Number: 16820965
• Product Code: OEQ
• UDI-Device Identifier: 10888439390377
• UDI-Public: 10888439390377
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/27/2020

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: SAN44CAUTA
• Device Catalogue Number: SAN44CAUTA
• Device Lot Number: 407795
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 05/27/2020
• 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