MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A1704, 6MM S/S STLTH CLP N/S 3/4 F 50/BG; DSS

Model Number A1704

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A follow-up report will be sent once the results have been analyzed.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.

Event Description

Open heart cabg - "customer reported clips, spring surgical stealth, repeatedly flew off the end of the patient's vein each time they tried to dilate, and it does not perform up to the standard needed to do the surgery." additional information received via email on january 03, 2016 - the entire clip came off the vessel.The clip was retrieved.The pa had no trouble placing the clip.Originally, the clip occluded the vein, however when the pa tried to dilate the vein, the clip came off.The pa was preparing the vein for a bypass graft.Staff did not seem to believe there was damage to the graft vessel.Another clip was opened to the field.The item is not available for return.Patient status: no adverse effects reported as a result of this complaint.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the event.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

• Brand Name: A1704, 6MM S/S STLTH CLP N/S 3/4 F 50/BG
• Type of Device: DSS
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: jennifer scoullar ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 6241534
• MDR Text Key: 64546492
• Report Number: 2027111-2017-00014
• Device Sequence Number: 1
• Product Code: DSS
• UDI-Device Identifier: 10607915110663
• UDI-Public: (01)10607915110663(11)171130(30)01(10)1184100
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K883909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2017
• Device Model Number: A1704
• Device Catalogue Number: 100579801
• Device Lot Number: 1184100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1