MAUDE Adverse Event Report: CONMED CORPORATION MARKED SPRING TIP GUIDEWIRE; ACCESSORIES FOR AMERICAN DILATORS: GUIDEWIRE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Bowel Perforation (2668)

Event Date 04/18/2016

Event Type  Injury  

Manufacturer Narrative

The ifu states, "warning: since the marked guidewire is a reusable device that is subjected to varied use and cleaning environments, the life span of the product cannot be guaranteed.In particular, less than 1% of the spring tips have been reported to have become dislodged during reuse or cleaning.Dislodgement of the spring tip during use may require endoscopic removal of the spring tip.Failure to remove the tip may lead to the perforation of the esophagus, stomach or bowel and the consequences customarily associated therewith, including death." also, "warning: 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." the recommended proper cleaning instructions are presented in the ifu.No manufacturing defects have been identified.A root cause investigation is not required at this time.

Event Description

As reported by user facility, the patient was admitted on (b)(6) 2016 for egd with dilatation.The marked spring tip guidewire was placed intact endoscopically.The scope was withdrawn and the dilator was thread over the guidewire.Upon withdrawing the dilator and guidewire, the spring was noted to have fractured at the very proximal site of the spring (where it attaches to the rigid part of the guidewire.) all components of the guidewire were withdrawn.The spring was simply hanging on by a small fragment.The stomach was reevaluated for injury and superficial gastric injury was noted.The patient was discharged and later that day was admitted to the hospital with abdominal pain and perforation.Medical intervention included duodenal perforation repair with graham patch.The patient was discharged 9 days after the incident.No further information is available on the patient's latest condition or any indication of long term adverse effects.The procedure report was subsequently obtained by conmed corporation from the user facility.Findings in the report include "the dilation of the esophagus was successful, there was mild resistance with no bleeding." the information for use (ifu), warns that, "the guidewire should not be advanced if resistance is met without determining the cause and taking remedial action." the device was not returned for examination, evaluation or failure analysis.No visual evidence (photographs) of failure was made available.A failure analysis of the complaint device could not be completed therefore the reported failure cannot be verified; the complaint is unconfirmed.The expiration and device manufacture dates are unknown.It is not known if the device was used past its useful life span, as this device is sold nonsterile and is reusable.There have been no prior adverse events related to this product and failure mode in the past 24 months.(b)(4).This failure mode is addressed in the risk document and the risk analysis shows an acceptable risk level.The reported complaint issue will continue to be monitored through the complaint system.

• Brand Name: MARKED SPRING TIP GUIDEWIRE
• Type of Device: ACCESSORIES FOR AMERICAN DILATORS: GUIDEWIRE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer Contact: rachel schott ; 525 french road; utica, NY 13502-5994
• MDR Report Key: 6094442
• MDR Text Key: 59718529
• Report Number: 3007305485-2016-00135
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K853274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 000150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 86