MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE VASCULAR ANGIOGRAPHY PACK (AGFTC)255; ANGIOGRAPHY/ANGIOPLASTY KIT

Model Number	SANHFAGFTC
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the investigation, device history record could not be reviewed as a lot number was not provided.Supplier reviewed records over the last 2 years, and no abnormal situation was found.There are 164 occurrences reported in the past 12 months.No sample was available for investigation, only photos were provided.Lint was seen on the wire.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.(=0.38 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.From the investigation, there is 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 the supplier will continue to monitor the trend of this type of incident.
Event or Problem Description
The customer reported that during an embolization in the liver/ sirs spheres embolization, there was linting of the or towels pwtb04-stm from the vascular angiography pack sanhfagftc onto the wires the towels were used to hold wire and catheter, to prevent them from bouncing off the table and to help with all the fluid on the table.There was no delay in procedure or patient injury reported.

• Brand Name: VASCULAR ANGIOGRAPHY PACK (AGFTC)255
• 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: 10299101
• Report Number: 1423537-2020-00485
• Device Sequence Number: 11554050
• Product Code: OEQ
• UDI-Device Identifier: 10888439507645
• UDI-Public: 10888439507645
• 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
• Report Date (Section B): 07/20/2020

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: SANHFAGFTC
• Device Catalogue Number: SANHFAGFTC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 07/20/2020
• 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