MAUDE Adverse Event Report: COOK INC HIWIRE NITINOL HYDROPHILIC WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number HW-038150

Device Problem Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2018

Event Type  malfunction  

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 Description

It was reported that the doctor was using a hiwire nitinol hydrophilic wire guide and needle from urotech gmbh during a percutaneous nephrolithotomy (pcnl).The doctor noticed that the wire tip had been slit while it was used to access though the needle cannula.The doctor then exchanged the device for a new hi-wire guide.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.

Event Description

No additional event information has been received since the last report submission on (b)(6) 2018.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Conclusion codes: (b)(4), cause not established.Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was also performed.This included a review of complaint history, the device history record, quality control data, and specifications.One opened package labeled rpn hw (b)(4) with label lot number 10981047 was received.The device was returned inside the protective coil with approximately 15cm of the wire protruding from the coil.Damage was visualized on the coating near the distal tip.The device was forwarded to the supplier for further investigation.According to the supplier investigation, the specimen presents an overall length of 150.05cm and a finished diameter of.03595¿ to.03700¿.A gage bushing certified to be.0380¿ passed over the length of the specimen with no more effort than the mass of the bushing sliding down the wire shaft unaided, except by gravity to either aspect of the skive damage.All diameter measurements were acquired with a non-contact, toolmakers scope after allowing the specimen device to become dry after hydrating the specimen device with blood-bank saline.After flushing the dispenser assembly with blood-bank saline, the specimen wire was removed and subjected to visual and tactile examination.The specimen coating appears visually and tactilely consistent when examined at 1x ¿ 18 inches, unaided, wet.The specimen presents skive/cut damage located 12.35 to 12.45cm from the distal tip in a proximal to distal orientation with no indication of missing material.Microscopically, the specimen coating appears to be worn and abraded, consistent with clinical use.Except where noted, the specimen device appears visually and dimensionally correct.A review of the device history records of the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.The device history records indicate this product was final inspection tested and was determined to be acceptable.As indicated in the precautions section of the device instructions for use (ifu), when using wire guide through a metal cannula/needle, use caution as damage may occur to outer coating.A complaint history search revealed one other complaint associated with the complaint device lot number (10981047).The other complaint was for a different issue; could not remove wire from the sheath.The supplier of the product investigated the complaint.A review of the device history records of the specimen device did not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.The supplier also noted in a review of the returned product that the specimen presents skive/cut damage located 12.35 to 12.45cm from the distal tip in a proximal to distal orientation, with no indication of missing material.Based on the evidence presented by the sample and the information provided by the supporting documentation, clinical and/or procedural factors appear to have impacted on the event as reported.The exact cause for this incident cannot be determined.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.

• Brand Name: HIWIRE NITINOL HYDROPHILIC WIRE GUIDE
• Type of Device: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7532829
• MDR Text Key: 108864135
• Report Number: 1820334-2018-01505
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002304734
• UDI-Public: (01)00827002304734(17)210319(10)10981047
• Combination Product (y/n): N
• PMA/PMN Number: K082536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/03/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2021
• Device Catalogue Number: HW-038150
• Device Lot Number: 10981047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 05/22/2018
• Supplement Dates Manufacturer Received: 08/03/2018
• Supplement Dates FDA Received: 08/03/2018
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 100