MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE CARDIAC CATH PACK (CCTAD)809; ANGIOGRAPHY/ANGIOPLASTY KIT

Model Number	SAN73CCTA3
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 0.175g / 10 pieces.No sample was available at the time of the investigation, but photos were provided.Based on the photos, blue lint was found.According to the supplier, or towels are made of cotton, so cotton fiber is born.The 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.(=0.38 g/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.The investigation revealed no abnormal situation happened during production; therefore, the root cause could not be determined.The complaint information was shared with the relevant sectors for their awareness.No action will be taken at this time, but the supplier will continue to monitor trends for this type of incident.
Event or Problem Description
Towels in the pack are linting during per-cutaneous coronary intervention (stent placement).The lint was found on the tip on the intra vascular ultrasound before it was inserted into the patient.Patient went home and is presumably doing fine.Although there was no injury, cardinal health is proactively filing a medwatch report for potential risk to the patient.

• Brand Name: CARDIAC CATH PACK (CCTAD)809
• 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: 10201737
• Report Number: 1423537-2020-00470
• Device Sequence Number: 14054630
• Product Code: OEQ
• UDI-Device Identifier: 10888439812114
• UDI-Public: 10888439812114
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2020

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: SAN73CCTA3
• Device Catalogue Number: SAN73CCTA3
• Device Lot Number: 421172
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 06/26/2020
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 77