MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE FEMORAL ANGIOGRAPHY (AFMME)503; ANGIOGRAPHY/ANGIOPLASTY KIT

Model Number	SAN30AFMMF
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.
Event or Problem Description
Doctor reported after drying hands with cotton towel pwtb04-stm from the femoral angiography pack san30afmmf during an interventional cardiology procedure he noticed his gloves had blue lint.No adverse event was reported.No further information was provided when requested.
Additional Manufacturer Narrative
Based on supplier investigation, device history record (dhr) review did not indicate any exception that could lead to the reported incident.The average linting data is 0.152g/10pcs.No sample was returned for investigation.Photo was provided.Blue lint was found on the glove.According to our supplier, the or towel is made of cotton, so cotton fiber is born.Supplier is continuously working with cardinal to better control the linting and have implemented several measures to improve it: suction 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/10pieces), in the folding process, supplier used one cloth pad under 100pieces 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.

• Brand Name: FEMORAL ANGIOGRAPHY (AFMME)503
• 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: 12277494
• Report Number: 1423537-2021-00658
• Device Sequence Number: 14127180
• Product Code: OEQ
• UDI-Device Identifier: 10887488908717
• UDI-Public: 10887488908717
• Combination Product (Y/N): N
• Initial Reporter State: PR
• 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): 08/16/2021

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: SAN30AFMMF
• Device Catalogue Number: SAN30AFMMF
• Device Lot Number: 629356
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 08/16/2021
• 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
• Patient Age: 4 YR