MAUDE Adverse Event Report: COOK INC ULTRATHANE AMPLATZ URETERAL STENT SET; FAD STENT, URETERAL

Model Number	N/A
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510k status: preamendment.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
The international customer reported that, during a left sided ureteric stent procedure in which a ultrathane amplatz ureteral stent set was employed, the black pusher would not advance up to the radiopaque band of the device.As a result, the physician used the stent delivery system with the black pusher not properly advanced up to the radioopaque band.The physician advanced the stent into the patient and cut the string before the stent was in place, and the stent was deployed in the incorrect position.The distal pigtail was in the ureter, and the proximal pigtail was outside of the kidney (and near the skin surface).The customer believes this occurred because the black pusher could not be used effectively to place the stent.The patient was required to return to the department for a second attempt at the left sided ureteric stent insertion, which was performed by another physician on (b)(6) 2018.The second stent was successfully implanted into the patient.The complaint device is reportedly available for return; however, as of the date of this report, no device has yet been received for evaluation.
Additional Manufacturer Narrative
Device evaluation: a review of the complaint history, drawings, dimensional verification, device history record, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.The cause was determined to likely be not following the ifu.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.
Additional Manufacturer Narrative
Additional information: additional information was requested and received (05mar2018): does the customer believe the pusher contributed to the incorrect placement of the stent? yes because the pusher could not be passed up to the radiopaque band to be able to push against the stent to deploy properly.Did the stent itself malfunction in any way? no.Please describe the other products and equipment used during the procedure (endoscope type and model, introducer, wire guide, etc.).Cook amplatz wire.The physician attempted to remove the stent by trying to snare it with a pair of forceps.He had to make a small incision and blunt dissection down to the stent that was subcutaneous.The forceps grabbed the stent and it was pulled out through the tract.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

• Brand Name: ULTRATHANE AMPLATZ URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7315347
• Report Number: 1820334-2018-00489
• Device Sequence Number: 16512998
• Product Code: FAD
• UDI-Device Identifier: 00827002097100
• UDI-Public: (01)00827002097100(17)201012(10)8287630
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UTSSW-8.5-26-AMP-RH
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/09/2018
• Supplement Date Received by Manufacturer: 04/18/2018; 03/12/2018
• Initial Report FDA Received Date: 03/05/2018
• Supplement Report FDA Received Date: 05/07/2018; 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZ WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Weight: 40