MAUDE Adverse Event Report: COOK INC PERFORMER INTRODUCER; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been requested and not yet received.The event is currently under investigation.
Event or Problem Description
It was reported that a performer introducer was used during an unspecified procedure.When this product was used with a competitor's device, the wire cut through the tip x 1cm, the wire became caught and thus unraveled and was very difficult to remove.Additional information was requested including patient outcome and not yet received.
Additional Manufacturer Narrative
The reported problem occurred during placement of an internal ureteral stent.The sheath was flanked through the renal pelvis and down the ureter.After the wire unraveled, the radiologist placed a second wire down beside the first so as not to lose access and removed both the damaged wire and the introducer.He then inserted a new introducer and carried on with the case.The patient¿s anatomy was reportedly neither tortuous nor calcified.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.One used performer introducer was returned for investigation.A compression at 12.7cm from the proximal end is noted.From the proximal end, a kink was noted at 17.6cm.From the distal end, a compression was noted at 4.5cm and 2.0cm.A cut 7 mm long from the distal tip is noted.An additional cut was noted 1mm in length from the distal tip.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 would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6684489
• Report Number: 1820334-2017-01579
• Device Sequence Number: 72355
• Product Code: DYB
• UDI-Device Identifier: 00827002081390
• UDI-Public: (01)00827002081390(17)200407(10)7759627
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2017

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: RCFW-8.0-38-30-RB
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 07/03/2017
• Supplement Report FDA Received Date: 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1