MAUDE Adverse Event Report: BRACCO DIAGNOSTIC INC PROTOCOL TOUCH ADMINISTRATION SET; RECTAL AND RIGID SIGMOIDOSCOPY

Lot Number 9189BBE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Bowel Perforation (2668)

Event Date 06/21/2019

Event Type  Injury  

Event Description

This spontaneous invalid device report was received by bracco (b)(4) from an health professional on 21-jun-2019 and sent to bracco (b)(4) on the same day.It refers to an (b)(6) female who underwent an unspecified diagnostic procedure using protocol touch administration set.Her medical history included change in bowel habit, isolated episode of explosive diarrhoea, pr bleeding and rectal and rigid sigmoidoscopy it was reported that, during the procedure, the tip of the ctc catheter passed through the wall of the rectum, no apparent resistance was felt by the experienced radiographer.Patient outcome was unknown.Most recent follow-up information received by bracco (b)(4) from the reporter on 24-jun-2019 and sent to bracco (b)(4) on 24-jun-2019.With follow-up information the case became valid.That included patient's age and gender, medical history and concomitant medications.Outcome: unknown.Additional information is expected company comment an (b)(6) female patient, with a history of change in bowel habit, isolated episode of explosive diarrhoea, pr bleeding and rectal and rigid sigmoidoscopy, underwent an unspecified diagnostic procedure using protocol touch administration set.It was reported that, during the procedure, the tip of the ctc catheter passed through the wall of the rectum, no apparent resistance was felt by the experienced radiographer.Patient outcome was unknown.Mechanical injury of the rectum and perforation due to the catheter placement could occur as a consequence of barotrauma related to luminal distention.It may happen when a more rigid barium enema tip is substituted for distention, typically as a result of loss of gas around the catheter in patients with poor tone.This increases the possibility for injury (1).Without information on the rigidity and integrity of the catheter used in this patient, no causality is assessable at the moment.1.Kim dh in "ct colonography: principles and practice of virtual colonoscopy" 2010.Corresponding case number: (b)(4).

Event Description

This spontaneous invalid device report was received by bracco uk from an health professional on (b)(6) 2019 and sent to (b)(6) on the same day.It refers to an 85 year-old female who underwent an unspecified diagnostic procedure using protocol touch administration set.Her medical history included change in bowel habit, isolated episode of explosive diarrhoea, pr bleeding and rectal and rigid sigmoidoscopy it was reported that, during the procedure, the tip of the ctc catheter passed through the wall of the rectum, no apparent resistance was felt by the experienced radiographer.Patient outcome was unknown.Most recent follow-up information received by bracco uk from the reporter on (b)(6)2019 and sent to bracco milan on (b)(6) 2019.With follow-up information the case became valid.That included patient's age and gender, medical history and concomitant medications.Most recent follow-up information, received from the manufacturer on (b)(6) 2019, incorporated above includes: medical device serial number was provided.The manufacturer informed that the insufflator unit is on route for testing by bracco's approved service provider.The unit will undergo general performance testing, to ensure proper functionality within the required specification criteria.With regard to the administration set, the customer has confirmed there is no stock left on site from the batch that was involved in this incident.Since they do not record lot numbers, this information was not able to be obtained.No other information provided.Outcome: unknown.Additional information is expected company comment an 85-year-old female patient, with a history of change in bowel habit, isolated episode of explosive diarrhoea, pr bleeding and rectal and rigid sigmoidoscopy, underwent an unspecified diagnostic procedure using protocol touch administration set.It was reported that, during the procedure, the tip of the ctc catheter passed through the wall of the rectum, no apparent resistance was felt by the experienced radiographer.Patient outcome was unknown.Mechanical injury of the rectum and perforation due to the catheter placement could occur as a consequence of barotrauma related to luminal distention.It may happen when a more rigid barium enema tip is substituted for distention, typically as a result of loss of gas around the catheter in patients with poor tone.This increases the possibility for injury (1).Without information on the rigidity and integrity of the catheter used in this patient, no causality is assessable at the moment.1.Kim dh in "ct colonography: principles and practice of virtual colonoscopy" 2010.Corresponding case number: (b)(4).

Event Description

This spontaneous invalid device report was received by bracco uk from an health professional on 21-jun-2019 and sent to bracco milan on the same day.It refers to an 85 year-old female who underwent an unspecified diagnostic procedure using protocol touch administration set.Her medical history included change in bowel habit, isolated episode of explosive diarrhoea, pr bleeding and rectal and rigid sigmoidoscopy.It was reported that, during the procedure, the tip of the ctc catheter passed through the wall of the rectum, no apparent resistance was felt by the experienced radiographer.Patient outcome was unknown.Medical device serial number provided as (b)(6).Investigation results have been provided by bracco group quality: the unit (s/n (b)(6) ) was repaired by (b)(4)on 06 sep 2019.It was found that the regulator was broken.Additional follow up revealed the following: the regulator was working but was extremely noisy.The pressure valve was additionally not functioning.The unit passed final calibration.The regulator, pressure valve (70 mmhg), and also the cap nut were replaced.The unit passed all final qc testing after repairs were completed.A subsequent investigation was requested from the manufacturing facility (northgate technologies, inc.).The device history record for s/n (b)(6) (manufactured feb 2017) was reviewed and passed all testing.Nothing out of the ordinary was noted.The lot of regulator components placed in this unit was received from 15aug2016 through 23jan2017.Sampling (as per an aql) showed the parts passed inspection criteria.The incoming inspection reports for the pressure relief valve was not reviewed as this part is not lot controlled.Based on nti's follow up investigation it is not possible to determine the root cause of the catheter passing through the patient's wall.It is important to note that based on (b)(4) testing the electrical safety valve was operating as expected and should there have been over pressure this valve would have relieved the pressure at 50mmhg.No systemic trend related to this type of ae or the involved defective component parts has been detected.The reported ae's was not attributed to a malfunction of the device.Device was repaired as required and returned to user site.Most recent follow-up information received by bracco uk from the reporter on 24-jun-2019 and sent to bracco milan on 24-jun-2019.With follow-up information the case became valid.That included patient's age and gender, medical history and concomitant medications.Most recent follow-up information, received from the manufacturer on 24-jul-2019 includes: medical device serial number was provided.The manufacturer informed that the insufflator unit is on route for testing by bracco's approved service provider.The unit will undergo general performance testing, to ensure proper functionality within the required specification criteria.With regard to the administration set, the customer has confirmed there is no stock left on site from the batch that was involved in this incident.Most recent follow-up information received from bracco group quality on 26-nov-2019 includes: investigation results were provided.Outcome: unknown.Case closed.Company comment: an 85-year-old female patient, with a history of change in bowel habit, isolated episode of explosive diarrhoea, pr bleeding and rectal and rigid sigmoidoscopy, underwent an unspecified diagnostic procedure using protocol touch administration set.It was reported that, during the procedure, the tip of the ctc catheter passed through the wall of the rectum, no apparent resistance was felt by the experienced radiographer.Patient outcome was unknown.The returned unit testing results from bracco and manufacturer's investigation concluded that the reported event was not attributed to a malfunction of the medical device.Based on the information on hands, it appears that the event is likely related to the procedure.In fact rectal injury without apparent resistance may occur during the insertion of the catheter in the rectal wall.Automatically, the puborectalis muscle forms a sharp curve approaching a right angle between the rectum and the anus.The tip of a catheter that is insert through the anus collides with the anterior rectal wall perpendicularly after approximately only 5 cm insertion.Additionally, it should be noted that a patient over 65 years presents a loss of mechanical strength of the colon wall making it more fragile.Corresponding case number: (b)(4).

• Brand Name: PROTOCOL TOUCH ADMINISTRATION SET
• Type of Device: RECTAL AND RIGID SIGMOIDOSCOPY
• Manufacturer (Section D): BRACCO DIAGNOSTIC INC; 155 pinelawn road, suite 230 n; melville NY 11747
• MDR Report Key: 8745537
• MDR Text Key: 149554327
• Report Number: 2411512-2019-00004
• Device Sequence Number: 1
• Product Code: FCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/26/2019

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: No Information
• Device Lot Number: 9189BBE
• Was Device Available for Evaluation?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/21/2019
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: 07/24/2019; 11/26/2019
• Supplement Dates FDA Received: 08/16/2019; 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 85 YR