MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A4GW6, LATIS DUAL LUMEN, 9MM-60CM; CATHETER, EMBOLECTOMY

Model Number	A4GW6
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Engineering confirmed that the tip of the catheter had separated from the body.Based on the condition of the returned unit, the reported event was caused by a material change, which made the device more susceptible to uv light.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical has recently implemented material and process enhancements intended to further minimize the potential for this type of event to occur.This report represents a combined initial and follow up.
Event or Problem Description
Cer 1 of 5: (b)(4).Cer 2 of 5: (b)(4).Cer 3 of 5: (b)(4).Cer 4 of 5: (b)(4).(additional cer created on 26nov2019 to log the additional damaged device received).Cer 5 of 5: (b)(4).(additional cer created on 10jan2020 for the tip fracture of the undamaged device).This morning i looked at few of these latis catheters (unopened from the same complaint lot (1312586) that were also returned from the same hospital.I looked at 4 of them and they all seemed to have the same problem.It too brittle and kinks easily.One of them broke when i attempted to remove it out of the package.I still have few unopened units that i can send to your team if your engineering team wants to evaluate them.Additional information received via email on 15oct2019 from quality control eng: the only new information is that when i tested few unopened units (from the same complaint lot#) that were also returned from the customer on sept 19, i realized they were also brittle.Additional information received via email on 17oct2019 from quality control eng: i have 7 units from lot#1312586 ref a4gw6 that i can return.Three units are opened units that broke when removed from the package.Remaining 4 are still sealed inside its packaging.Additional information received via email on 31oct2019 from quality control eng: please note i have only 3 non-sterile and 3 sterile units from lot# 1312586.Additional information received via email on 25nov2019 from applied medical [engineer], and through discussion on 26nov2019 with applied medical [engineer]: 5 non-sterile devices were received for investigation.3 devices already had cers made for them.1 device was undamaged and no cer is needed for this device.This device will be logged in this complaint (#(b)(4)) as an additional returned device.The other device was damaged, with a missing tip, and will be logged as a new complaint under complaint # (b)(4).Picture of returned devices is available.Additional information was received via e-mail on 10jan2020 from [engineer] applied medical regarding the undamaged device that has been returned: a separate complaint wasn¿t created for the unit that was intact upon return.However, the tip fractured during follow up testing today.Photos are provided.Patient status: no patient involvement.

• Brand Name: A4GW6, LATIS DUAL LUMEN, 9MM-60CM
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9619175
• Report Number: 2027111-2020-00326
• Device Sequence Number: 10899365
• Product Code: DXE
• UDI-Device Identifier: 00607915111175
• UDI-Public: (01)00607915111175(17)201206(30)01(10)1312586
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K973465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 12/06/2020
• Device Model Number: A4GW6
• Device Catalogue Number: 100846901
• Device Lot Number: 1312586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1