MAUDE Adverse Event Report: EZEM PROTOCO21 SET FOR COLON INSUFFLATION

Model Number PROTOCO21 REF 6450

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2014

Event Type  No Answer Provided  

Event Description

Narrative: case received from a head nurse through bracco imaging europe bv on (b)(6)2014 and forwarded to quintiles ls (working on behalf of bracco) on the same day with invalid patient information.On (b)(6)-2014 live follow-up with valid patient details was received from the same sources and included in the initial report.A health professional reports: an (b)(6)old female patient underwent an unknown diagnostic procedure with protoco21 set for colon insufflation ((b)(6), lot number 50736677) on (b)(6)2014.Subsequently the cannula inflated with air exploded in the patient's colon.There was no clinical consequence, no pain during the explosion of the balloon.No other products were used with the protoco21 set.

Manufacturer Narrative

Outcome: recovered/resolved.Further information has been requested.(b)(4) 2014: follow-up information was received from a physician from a physician via bracco imaging (b)(4)through bracco imaging s.P.A and forwarded to quintiles ls on the same day.Indication for the virtual colonoscopy was the investigation of a left colon injury.Insufflation was performed manually.The retention cuff insufflator that is provided with the catalogue 6450 administration set was used to inflate the retention cuff.The retention cuff inflator squeezed once.Air at room temperature (1 puff) from the one shot puffer was insufflated.The procedure was not difficult and the experience of the staff performing the procedure was all right.They became aware that the balloon had exploded, as they had the impression that the balloon was deflating at the end of the procedure.There was no further information available with regard to the medical history and complete history of prior surgeries/procedures (e.G.Barium enema, colonoscopy, etc.) of the patient, to concomitant medications and indications, or any pre-existing gastrointestinal conditions.(e.G.Diverticulosis, polyps, malignancy, inflammatory bowel disease, etc.).Outcome: recovered/resolved.Final manufacturer comment awaited.Regulatory number: (b)(4).Worldwide case id: (b)(4).As preliminary investigation, all the associated lot document was carefully reviewed and no issues or discrepancies were found which could potentially relate to the reported complaint.Prior to final product release, this review is also performed to confirm that all devices meet material, assembly and performances specifications.Company comments: a (b)(6) female patient underwent a virtual colonoscopy with protoco21 set for colon to investigate a left colon injury.No further information was available with regard to patient's medical history, including pre-existing gastrointestinal conditions (e.G.Diverticulosis, polyps, malignancy, inflammatory bowel disease, surgeries/procedures etc.), patient's concomitant medications.At the end of the procedure the radiologist had the impression that the balloon was deflating and it became aware that the balloon had exploded.There was no clinical consequence for the patient due to the event.With regards to technical procedural aspects, the radiologist specified that 1 puff air at room temperature was insufflated in the protoco21 colon insufflator retention cuff.No other parameters or actions performed during the exam had been reported.To perform ct colonoscopy a very small, flexible tube is inserted into patient's rectum to allow air to be gently pumped into the colon.Sometimes a small balloon is inflated on the recta tube to help keep the tube positioned correctly.As reported in the labeling, care must be taken to avoid over-inflation of the balloon since over-inflation may lead to rectal perforation, or vasovagal reactions, or may cause, as in our case, the balloon to deflate.Based on the above, the manufacturer has decided to have a conservative approach and to report this case.

• Brand Name: PROTOCO21 SET FOR COLON INSUFFLATION
• Type of Device: SET FOR COLON INSUFFLATION
• Manufacturer (Section D): EZEM; 532 broadhollow road; melville NY 11747
• Manufacturer (Section G): EZEM; 532 broadhollow road,; melville NY 11747
• Manufacturer Contact: 259 prospect plains rd. bld.h,; monrow twp, NJ 08831 ; 8002575181
• MDR Report Key: 4147108
• MDR Text Key: 16173533
• Report Number: 2411512-2014-00008
• Device Sequence Number: 1
• Product Code: FCX
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PROTOCO21 REF 6450
• Device Catalogue Number: PAGE 12 BRACCO CATALOGUE
• Device Lot Number: 50736677
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2014
• Patient Sequence Number: 1
• Patient Age: 81 YR