MAUDE Adverse Event Report: E-Z-EM, INC. (A SUBSIDIARY OF BRACCO DIAGNOSTICS I PROTOCOL VC ADM. SET/DELIVERY SYST. FOR PROTOCOL COLON INSUFFLATOR 6470; PROTOCOL VC ADMINISTRATION SET FOR PROTOCOL COLON INSUFFLATOR 6470

Model Number 650004

Device Problem Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2021

Event Type  malfunction  

Manufacturer Narrative

This case was received from a healthcare professional (technologist) on (b)(6) 2021 by a bracco affiliate and was sent to bracco drug safety unit (dsu) on the same day ((b)(6)2021).On 15-feb-2021 and 18-feb-2021, additional information was provided.All information was incorporated into the initial report.On (b)(6) 2021, a female patient, age unknown, underwent a virtual colonoscopy with use of the protocol administration set due to family history and colon cancer screening.During the procedure, the retention balloon exploded in the colon when the patient turned on her right side.Once the cannula was removed, the plastic on the balloon was not on the catheter, but inside the colon.The patient made a "fleet" to expel the piece of balloon.It was reported the incident recovered on the same day ((b)(6) 2021).According to the reporter, the device was used in accordance with the user instruction.The balloon was inflated with 25 ml of air prior to the incident.The reporter believed the cause of this incident was due to the weakness in the plastic of the balloon (product quality issues).The procedure was completed, and the examination images were diagnostically useful.The patient did not experience any adverse reaction.This case is medically closed.Bracco comment: the colon insufflator administration set was used in accordance with the user instructions.Whilst in situ, the protocol touch administration set retention balloon exploded in the colon when the patient turned on her right side.Once the cannula was removed, the plastic on the balloon was not on the catheter, but inside the colon.The patient made a "fleet" to expel the piece of balloon.Balloon inflation prior to fault was 25 mls.The procedure was completed and the examination quality was not compromised due to the bursting balloon.There was no injury to the patient.The reporter believed the cause of this incident was due to the weakness in the plastic of the balloon.Although no adverse event occurred in this patient, and inflation with 25 mls was within the recommended inflation volume, direct rectal damage through either mechanical injury or barotrauma through the bursting balloon cannot be excluded, therefore this case was assessed as reportable.

Event Description

This case was received from a healthcare professional (technologist) on (b)(6) 2021 by a bracco affiliate and was sent to bracco drug safety unit (dsu) on the same day ((b)(6)2021).On 15-feb-2021 and 18-feb-2021, additional information was provided.All information was incorporated into the initial report.On (b)(6) 2021, a female patient, age unknown, underwent a virtual colonoscopy with use of the protocol administration set due to family history and colon cancer screening.During the procedure, the retention balloon exploded in the colon when the patient turned on her right side.Once the cannula was removed, the plastic on the balloon was not on the catheter, but inside the colon.The patient made a "fleet" to expel the piece of balloon.It was reported the incident recovered on the same day ((b)(6) 2021).According to the reporter, the device was used in accordance with the user instruction.The balloon was inflated with 25 ml of air prior to the incident.The reporter believed the cause of this incident was due to the weakness in the plastic of the balloon (product quality issues).The procedure was completed, and the examination images were diagnostically useful.The patient did not experience any adverse reaction.This case is medically closed.Bracco comment: the colon insufflator administration set was used in accordance with the user instructions.Whilst in situ, the protocol touch administration set retention balloon exploded in the colon when the patient turned on her right side.Once the cannula was removed, the plastic on the balloon was not on the catheter, but inside the colon.The patient made a "fleet" to expel the piece of balloon.Balloon inflation prior to fault was 25 mls.The procedure was completed and the examination quality was not compromised due to the bursting balloon.There was no injury to the patient.The reporter believed the cause of this incident was due to the weakness in the plastic of the balloon.Although no adverse event occurred in this patient, and inflation with 25 mls was within the recommended inflation volume, direct rectal damage through either mechanical injury or barotrauma through the bursting balloon cannot be excluded, therefore this case was assessed as reportable.(b)(4).

Manufacturer Narrative

This case was received from a healthcare professional (technologist) on 11-feb-2021 by a bracco affiliate and was sent to bracco drug safety unit (dsu) on the same day (11-feb-2021).On 15-feb-2021 and 18-feb-2021, additional information was provided.All information was incorporated into the initial report.On (b)(6) 2021, a female patient, age unknown, underwent a virtual colonoscopy with use of the protocol administration set due to family history and colon cancer screening.During the procedure, the retention balloon exploded in the colon when the patient turned on her right side.Once the cannula was removed, the plastic on the balloon was not on the catheter, but inside the colon.The patient made a "fleet" to expel the piece of balloon.It was reported the incident recovered on the same day ((b)(6) 2021).According to the reporter, the device was used in accordance with the user instruction.The balloon was inflated with 25 ml of air prior to the incident.The reporter believed the cause of this incident was due to the weakness in the plastic of the balloon (product quality issues).The procedure was completed, and the examination images were diagnostically useful.The patient did not experience any adverse reaction.This case is medically closed.Bracco comment: the colon insufflator administration set was used in accordance with the user instructions.Whilst in situ, the protocol touch administration set retention balloon exploded in the colon when the patient turned on her right side.Once the cannula was removed, the plastic on the balloon was not on the catheter, but inside the colon.The patient made a "fleet" to expel the piece of balloon.Balloon inflation prior to fault was 25 mls.The procedure was completed and the examination quality was not compromised due to the bursting balloon.There was no injury to the patient.The reporter believed the cause of this incident was due to the weakness in the plastic of the balloon.Although no adverse event occurred in this patient, and inflation with 25 mls was within the recommended inflation volume, direct rectal damage through either mechanical injury or barotrauma through the bursting balloon cannot be excluded, therefore this case was assessed as reportable.

Event Description

This case was received from a healthcare professional (technologist) on 11-feb-2021 by a bracco affiliate and was sent to bracco drug safety unit (dsu) on the same day (11-feb-2021).On 15-feb-2021 and 18-feb-2021, additional information was provided.All information was incorporated into the initial report.On (b)(6) 2021, a female patient, age unknown, underwent a virtual colonoscopy with use of the protocol administration set due to family history and colon cancer screening.During the procedure, the retention balloon exploded in the colon when the patient turned on her right side.Once the cannula was removed, the plastic on the balloon was not on the catheter, but inside the colon.The patient made a "fleet" to expel the piece of balloon.It was reported the incident recovered on the same day (b)(6) 2021.According to the reporter, the device was used in accordance with the user instruction.The balloon was inflated with 25 ml of air prior to the incident.The reporter believed the cause of this incident was due to the weakness in the plastic of the balloon (product quality issues).The procedure was completed, and the examination images were diagnostically useful.The patient did not experience any adverse reaction.On (b)(6) 2021, the results of quality investigation of the flex baloon by the supplier became available.Based on the present analysis, it is determined that reported complaint is not confirmed and is not related tosuppliers manufacturing process since defect was not confirmed during sample evaluation and no discrepancies and/or deviations where documented that could be related to the reported defect, therefore it's consider that other external causes could have affected the product integrity such as handling, non-proper usage or any other possible contributor out of the flex control.Most recent follow-up information incorporated above includes: on (b)(6) 2021: the supplier's flex baloon quality investigation report was provided.This case is medically closed.Bracco comment: the colon insufflator administration set was used in accordance with the user instructions.Whilst in situ, the protocol touch administration set retention balloon exploded in the colon when the patient turned on her right side.Once the cannula was removed, the plastic on the balloon was not on the catheter, but inside the colon.The patient made a "fleet" to expel the piece of balloon.Balloon inflation prior to fault was 25 mls.The procedure was completed and the examination quality was not compromised due to the bursting balloon.There was no injury to the patient.The reporter believed the cause of this incident was due to the weakness in the plastic of the balloon.Although no adverse event occurred in this patient, and inflation with 25 mls was within the recommended inflation volume, direct rectal damage through either mechanical injury or barotrauma through the bursting balloon cannot be excluded, therefore this case was assessed as reportable.Udi#: (b)(4).Corresponding worldwide case id: (b)(4).

• Brand Name: PROTOCOL VC ADM. SET/DELIVERY SYST. FOR PROTOCOL COLON INSUFFLATOR 6470
• Type of Device: PROTOCOL VC ADMINISTRATION SET FOR PROTOCOL COLON INSUFFLATOR 6470
• Manufacturer (Section D): E-Z-EM, INC. (A SUBSIDIARY OF BRACCO DIAGNOSTICS I; 259 prospect plains road; monroe township NJ 08831
• MDR Report Key: 11404292
• MDR Text Key: 280448710
• Report Number: 2411512-2021-00001
• Device Sequence Number: 1
• Product Code: FCX
• Combination Product (y/n): N
• PMA/PMN Number: K030854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 650004
• Device Lot Number: 60223240
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 03/03/2021
• Supplement Dates Manufacturer Received: 03/03/2021
• Supplement Dates FDA Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1