MAUDE Adverse Event Report: COOK ENDOSCOPY ECLIPSE TTC WIRE GUIDED BALLOON DILATOR; KNQ, DILATOR, ESOPHAGEAL

Catalog Number ECL-18X5.5

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: inflation device (unknown type), cook metii-035 wire guide.The event is still currently under investigation.Once the investigation is completed, a follow up report will be sent to reflect our findings.

Event Description

During a stricture dilation procedure, the physician used a cook eclipse ttc wire guided balloon dilator.While inserting the lubricated balloon catheter, the catheter got stuck in the scope accessory channel and further attempt [when further attempt was made to advance through the scope], catheter breakage [the catheter broke] and failure to advance it through endoscope channel.On 01/13/2016, additional information was received that the sheath detached inside of the endoscope.

Event Description

This follow up report is being sent to cancel the initial report submitted relating to this event because additional information was provided.Please reference the following sections for justification: description of event and patient outcome.During a stricture dilation procedure, the physician used a cook eclipse ttc wire guided balloon dilator.While inserting the lubricated balloon catheter, the catheter got stuck in the scope accessory channel and further attempt [when further attempt was made to advance through the scope], catheter breakage [the catheter broke] and failure to advance it through endoscope channel.On 01/11/2016, the device was returned for evaluation.Upon initial evaluation, it was discovered that the coil spring had detached from the stylet.The coil spring was not included with the return of the device.It was later confirmed that the coil spring was not located in the endoscope either.On 01/13/2016, additional information was received that the sheath detached inside of the endoscope.On 01/19/2016, additional information was received that the additional procedures of the laparotomy and colon resection were performed due to physician preference as the physician is a surgeon.

• Brand Name: ECLIPSE TTC WIRE GUIDED BALLOON DILATOR
• Type of Device: KNQ, DILATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 5370062
• MDR Text Key: 36076362
• Report Number: 1037905-2016-00009
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K935094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2016

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECL-18X5.5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/05/2015
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/09/2015
• Initial Date FDA Received: 01/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 60