MAUDE Adverse Event Report: COOK INC ROADRUNNER DOUBLE FLEXIBLE HYDROPHILIC WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number	G18792
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
It was reported, during a ureteroscopy stenting procedure, when inserting the stent with the expiration date of 02dec2017, the stent did not advance on the roadrunner double flexible hydrophilic wire guide.It was noticed the surface of the wire was notched which prevented the stent from advancing on the wire.As reported, the notch was described as the "surface peeling off".Another wire guide was used to complete the procedure.No adverse events have been reported as a result of the alleged malfunction.
Additional Manufacturer Narrative
Conclusions code: shelf life/expiration date exceeded (192).Investigation ¿ evaluation: a visual inspection and dimensional verification of the returned device was conducted.A document based investigation was performed including a review of complaint history, the device history record, drawings, manufacturing instructions, and quality control data.The device was returned opened and used.It is approximately 150cm in length.Both the proximal and distal tips are intact and undamaged.There is damage on the jacket noted at approximately 15.5cm, 20.5cm, 23.5cm, 42cm, 62.5cm, 72.5cm, 92.5cm, and 123.5cm from the proximal end.The damage at these locations vary from small scratches to cuts that breach the jacket entirely.The outer diameter is out of specification at these areas, but this cannot be confirmed to be a manufacturing defect since it is possible this damage was caused by forcing the stent over these areas.The distal ink marks are partially scratched off.There is no indication of any internal separation.The device history record was reviewed and there were no non-conformances noted.It was noted that the records show the device expiration date of december 2017.A search of complaint records revealed this is the only complaint associated with complaint lot number 5484406.The device manufacturing record was reviewed and no notable gaps in production or processing controls were noted.A definitive conclusion was made.The package label notes that the expiration date of the product is december 2017.The customer reported using this product (b)(6) 2018, which is past the expiration date.It was found that the expiry of this product was a contributing factor to the reported device failure.A letter has been sent to the customer regarding the results of this investigation.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Additional information received on 22aug2018.A cook universa stent was used with the wire guide.

• Brand Name: ROADRUNNER DOUBLE FLEXIBLE HYDROPHILIC WIRE GUIDE
• Common Device Name: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7686451
• Report Number: 1820334-2018-01845
• Device Sequence Number: 10921233
• Product Code: OCY
• UDI-Device Identifier: 00827002187924
• UDI-Public: (01)00827002187924(17)171202(10)5484406
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K082536
• 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
• Report Date (Section B): 09/13/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/02/2017
• Device Model Number: G18792
• Device Catalogue Number: RSPC-035145-DF-I-AQ
• Device Lot Number: 5484406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 09/13/2018
• 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: CYSTOSCOPE, URETEROSCOPE, ACCESS SHEATH, LASER; CYSTOSCOPE, URETEROSCOPE, ACCESS SHEATH, LASER
• Patient Age: 60 YR