MAUDE Adverse Event Report: COOK INC AMPLATZ EXTRA STIFF PTFE FIXED CORE WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number	N/A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported during a percutaneous nephrostolithotomy procedure for stone removal the coating was noted to be peeling off the product.Upon completion of the procedure, during check up, three small blue particles where seen inside the renal pelvis.The three small blue particles remain inside the renal pelvis.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.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, specifications, quality control and visual inspection of the device was conducted during the investigation.The visual inspection of the device photo¿s reported that: a review of the supplied photo(s) reveals what appear to be areas where blue coating is sheared off.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Investigation revealed that there were multiple nonconformances in the production process that were detected and scrapped in-house; however, this complaint is the first complaint from the field regarding this lot.A review of documentation revealed that in manufacturing the devices are 100% inspected for coating defects.Biocompatibility testing has been completed for the completed device.Risk assessment and escalation to review board determined that additional risk reduction was not required.A process change was previously initiated due to high occurrence rate of this failure mode and has now been implemented to improve the adherence of the ptfe coating to the wire guide.The complaint device was not produced via the improved process.Based on the information provided, the root cause of this complaint is determined to be manufacturing related and the appropriate personnel have been notified.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: AMPLATZ EXTRA STIFF PTFE FIXED CORE WIRE GUIDE
• Common Device Name: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6024198
• Report Number: 1820334-2016-01096
• Device Sequence Number: 544947
• Product Code: OCY
• UDI-Device Identifier: 00827002535602
• UDI-Public: (01)00827002535602(17)190517(10)6923745
• Combination Product (Y/N): N
• PMA/510(K) Number: K082536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: AES-038145
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2016
• Supplement Report FDA Received Date: 03/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other