MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF01, 5X150 KII FIOS ZTHR 6/BX; GCJ

Model Number	1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: laparoscopic peritoneal dialysis catheter insertion.Event description: 1st cer: 2017-0802, 2nd cer: 2017-0803.Dr.(b)(6) was performing this procedure.He tried to introduce this port as his primary trocar insertion.The patient had a thick abdominal wall (dr.(b)(6) estimated 5 cm.).The trocar got through the anterior fascia and other layers fine but got resistance at the posterior fascia.Dr.(b)(6) continued to try to enter when the cannula and obturator bent in half.He tried a second trocar with the same result, then he broke scrub to try to find a different trocar or another solution.The dir.Of surgical services advised him they have no other option and to try again, which he did and was able to enter the fascia and peritoneum, and the procedure then proceeded as planned.Dr.(b)(6) feels this issue resulted in over ten minutes of increased procedure time and "extra holes in the patient's fascia".Additional information received via telephone from sales rep on may 3, 2017 - it was described that a 10-2 motion and proper technique were being used.It is unknown if the doctor bent the products more the after procedure.Type of intervention: na.Patient status: no patient injury.The patient is recovering as expected.
Additional Manufacturer Narrative
The event product was returned to applied medical for evaluation along with nine sterile units.Upon inspection of the event unit, engineering was able to confirm the complainant's experience of a bent cannula and obturator.The cannula and obturator were both fractured at the site of the bend.No damage was noted on the nine sterile units returned.The likely root cause of the damaged trocar is a combination of insertion force and material degradation during the molding process, which could cause the part to be more prone to fractures.The probability and criticality of harm resulting from this failure mode have been evaluated and were found to be at an acceptable level.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: CTF01, 5X150 KII FIOS ZTHR 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6596107
• Report Number: 2027111-2017-01796
• Device Sequence Number: 760569
• Product Code: GCJ
• UDI-Device Identifier: 00607915124014
• UDI-Public: (01)00607915124014(17)191222(30)01(10)1286079
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: 1
• 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,Followup
• Report Date (Section B): 06/26/2017

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: Other
• Device Expiration Date: 12/22/2019
• Device Model Number: 1
• Device Catalogue Number: 1
• Device Lot Number: 1286079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 06/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1