MAUDE Adverse Event Report: BRACCO DIAGNOSTICS, INC. ADMINISTRATION SET FOLEY CATHETER; PROTOCO2L COLON INSUFFLATOR ADMINISTRATION SET FOLEY CATHETER

Model Number 6470

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2014

Event Type  No Answer Provided  

Event Description

Case received from a pharmacist, radiologist and a radiology technician via (b)(6) on (b)(6) 2014 and forwarded to (b)(4) on the same day.On 10/21/2014, live follow-up was received from the same sources and included in the initial report.Health professionals report: a (b)(6) male patient with medical history of stroke, appendectomy at the age of (b)(6) and ablation of one micro polyp during colonoscopy in (b)(6) 2014, but without history of gastrointestinal disease, underwent a ct virtual colonoscopy with protoco21 for colon insufflation set foley catheter (ref.6450, lot number unk) on (b)(6) 2014 due to incomplete visualization of the right angle of colon during the colonoscopy in (b)(6) 2014.The balloon was inflated with 50 ml of air twice (35 ml and 15 ml).Before introduction into the rectum the balloon inflation had been tested with the same amount of air.During the procedure the balloon exploded while the patient changed from dorsal to lateral position.The patient had noticed a change and the imaging team realized that the balloon had exploded.The procedure was stopped, but could be restarted and finalized without problem on the same day with another balloon administration set foley catheter.No medical consequences at all occurred for the patient.Outcome: unk.This case is medically closed.November 21, 2014: follow-up information was received from the (b)(4)authority (b)(6) on (b)(6) 2014 and forwarded to (b)(4) on the same day.Furthermore, a receipt confirmation of the last submission with the ansm number was received via landmail directly at (b)(4).The authority confirmed the final assessment of case number (b)(4), regarding an incident on administration set foley catheter.No further investigation was planned.Outcome: unk.This case is medically closed.(b)(4).

Manufacturer Narrative

A (b)(6) male patient underwent a ct colonoscopy with protoco2l set for colon insufflation, as during a previous colonoscopy the right colon angle could not be visualized.The patient had no history of gastrointestinal disease.However, during the colonoscopy performed 3 months ago, one micro polyp was removed.Other medical history included appendectomy at the age of (b)(6) and stroke.During the procedure, while changing position, the patient noticed a change, and subsequently the imaging team noted that the balloon had exploded.There was no clinical consequence for the patient due to the event and the procedure could be completed with another balloon on the same day.To perform ct colonoscopy thin catheter with small balloon is generally used.Explosion of the balloon might occur and this could be the result of a balloon over-distention or of a variation of the resultant force between the external and internal pressure of the balloon.In this case, the balloon inflation had been tested before its insertion into the rectum.The total amount of air used to inflate the balloon was 50 ml (35 ml plus 15 ml).The incident has been considered possibly related to the procedure since the balloon explosion occurred when the patient change position (e.G.From dorsal decubitus to lateral decubitus).In fact, during the ct colonoscopy, when the patient change the position from supine to prone a higher pressure up to 40-50 mmhg could be generated into the colon instead of the optimal one of 25 mmhg.In this circumstance, a variation of the resultant force between the external and internal pressure of the balloon could occur and determine and explosion/deflation of the balloon.Based on the above, even though the event is considered not manufacturing related but procedural related, the manufacturer has decided to have a conservative approach and to report this case.

• Brand Name: ADMINISTRATION SET FOLEY CATHETER
• Type of Device: PROTOCO2L COLON INSUFFLATOR ADMINISTRATION SET FOLEY CATHETER
• Manufacturer (Section D): BRACCO DIAGNOSTICS, INC.; 532 broadhollow rd.; melville NY 11747
• Manufacturer (Section G): EZEM; 532 broadhollow road; melville NY 11747
• Manufacturer Contact: 259 prospect plains rd.; bldg h; monrow twp, NJ 08831 ; 8002575181
• MDR Report Key: 4360353
• MDR Text Key: 5118288
• Report Number: 2411512-2014-00013
• Device Sequence Number: 1
• Product Code: FCX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K0303854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 6470
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2014
• Patient Sequence Number: 1
• Treatment: KARDEGIC (ACETYLSALICYLATE LYSINE)
• Patient Age: 68 YR
• Patient Weight: 100