MAUDE Adverse Event Report: CONMED CORPORATION MARKED SPRING TIP GUIDEWIRE; ESOPHAGEAL DILATOR

Catalog Number	000150
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One (1) 000150 marked spring tip guidewires has been returned to the conmed quality assurance laboratory for evaluation regarding a complaint of "when the wire was removed after dilation, it was bent to the point where it couldn't be used." the device was examined in the laboratory; a visual inspection noted the spring tip was fractured at the soldered wire winding approximately 60mm from the distal end.The stainless steel wound wire has been bent at a 20° angle.The wire has not detached.An examination of the fracture reveals a ductile fracture with no evidence of void, inclusion or other defects.The complaint is confirmed.The apparent cause is fracture of the solder joint due to excessive force.The damage appears to be user related.This lot was manufactured on 05-oct-2016.Of the lot containing (b)(4) units, there have been no other similar complaints.A 2-year review of the device complaint history showed seven (7) similar complaints received for "bend", including this reported event.During this same 2-year time frame, over (b)(4) units were sold worldwide, making the occurrence rate for this failure mode (b)(4).This failure mode is addressed in the risk document with an acceptable risk level.No evidence of manufacturing or material defects were observed.A review of the manufacturing documents from the dhr/lhr has verified the devices were produced according to current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture.No further investigation is planned at this time; however, the reported complaint issue will continue to be monitored through the complaint system.The marked spring tip guidewire is a nonsterile, reusable 210 cm long solid metal mandrel with a flexible variable thread spring attached to it.The guidewire is to be used with american dilators and is compatible with key med, savary, eder puestow, and celestin esophageal systems.To reduce the risk of the spring tip bend and/or breakage, and to reduce patient injury, the ifu provides the following warnings: "the guidewire should not be advanced if resistance is met without determining the cause and taking remedial action." "carefully inspect the guidewire after each use.Inspect the flexible spring tip and discard the wire if the tip appears to be bent or fatigued.Also inspect the soldered joints and discard the wire if the soldered joints appear discolored, loose or cracked.".
Event or Problem Description
The user facility reported that while using the conmed marked spring tip guidewire during an egd (esophagogastroduodenoscopy) on (b)(6) 2017, "the doctor did a standard 54 fr dilation on the patient, under normal conditions.The wire was brand new out of the package and passed down the scope, which was relatively straight, but when the wire was removed after dilation, it was bent to the point where it couldn't be used." there was no patient or user injury with this reported incident.To date there has been no additional information received regarding the patient's latest condition or any indication that long term adverse effect has occurred.This report is filed on the basis of potential injury with recurrence.

• Brand Name: MARKED SPRING TIP GUIDEWIRE
• Common Device Name: ESOPHAGEAL DILATOR
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 6360406
• Report Number: 3007305485-2017-00035
• Device Sequence Number: 35663
• Product Code: KNQ
• UDI-Device Identifier: 30653405050852
• UDI-Public: (01)30653405050852(11)161005(10)201610054
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K853274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/27/2017

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: Physician
• Device Catalogue Number: 000150
• Device Lot Number: 201610054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1