MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES B7216, FORTE AXP SHTH 10/12/16 35CM; FED

Model Number	B7216
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of the investigation.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.There is no report of serious injury or death associated with this event.
Event or Problem Description
Cystoscopy & right retrograde pyelogram & ureteroscopy: "end of forte ap access sheath broke off, wedging in the ureter".Type of intervention - additional information received via phone (b)(6) 2016: "did remove the small piece but did lazer the piece to remove which caused some damage to piece that fell off." additional information received via e-mail (b)(6) 2016: all of the pieces were completely removed from the patient.The access sheath was passed over the guidewire to the iliac vessel level.The obturator was removed and wire passed through the outer sheath.On removing the outer sheath the piece was noted in the lower ureter on screening.The procedure did not continue after the removal of the foreign body.Additional information received via e-mail (b)(6) 2016: the tip was retrieved with no adverse outcomes for the patient.Additional information received via e-mail (b)(6) 2016: the surgeon had to use a laser to remove the piece that had broken off.The piece was lodged in the vessel.This resulted in a stent needing to be placed in the area of the lasered removal.It was not directly stated that the laser caused damage to the piece in question, only that a laser was used to remove the piece which was lodged in the patient.Patient status - "no adverse outcomes for patient.".
Additional Manufacturer Narrative
Investigation summary: the forté ureteral access sheath, dilator and tip fragment were returned for evaluation.Engineering visually confirmed the complainant's experience of tip breakage.Additional information received from the complainant verified that the tip was retrieved with no adverse outcomes for the patient.The exact root cause of the event could not be determined.Although the tip fragment was returned, the use of a laser during its removal resulted in damage that made it difficult to determine the root cause of the separation.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.In accordance with 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then the supplemental report will be submitted to the fda.

• Brand Name: B7216, FORTE AXP SHTH 10/12/16 35CM
• Common Device Name: FED
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5904017
• Report Number: 2027111-2016-00591
• Device Sequence Number: 472530
• Product Code: FED
• UDI-Device Identifier: 00607915113353
• UDI-Public: (01)00607915113353(17)170818(30)01(10)1229438
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K993650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2017

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: 08/18/2017
• Device Model Number: B7216
• Device Catalogue Number: 100794801
• Device Lot Number: 1229438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/25/2016
• Supplement Report FDA Received Date: 02/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1