MAUDE Adverse Event Report: BRACCO DIAGNOSTICS INC PROTOCOL TOUCH

Model Number SN390305-5158

Device Problems Deflation Problem (1149); Use of Device Problem (1670)

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Discomfort (2330)

Event Date 09/24/2018

Event Type  malfunction  

Event Description

The patient had a scan and was successfully completed.The catheter was removed from the patient without the balloon being deflated.The patient felt discomfort.The following day the patient called to say that she was bleeding through her back passage and had abdominal pain.She was advised to come in and be seen by the surgeons, in ae.The patient was seen by the surgeons in ae and discharged.Patient was not hospitalised, however was seen by surgeons in ae and thereafter discharged.Corresponding worldwide case id# (b)(4).

Event Description

This spontaneous device report was received by bracco uk from a health professional on (b)(6)2019 and sent to bracco milan on the same day.It refers to a 58 year-old female patient who underwent a ct scan using protocol admin set.Patient's medical history was not reported.Concomitant illness and concomitant medications were not provided.On (b)(6)2018 the patient had a ct scan using protocol admin set (serial no: 390305-5158, batch no.60167134, expiry date: (b)(6) 2022) and it was successfully completed.The catheter was removed from the patient without the balloon being deflated and she felt discomfort.The following day the patient called to say that she was bleeding through her back passage and had abdominal pain.She was advised to come in and be seen by the surgeons in emergency department.The patient was seen by the surgeons and discharged.It was specified that she was not hospitalized.At the time of this report the patient is recovering.Investigation results have been provided by bracco group quality: based on a review of the device history records for batch 60167134, the product was produced in accordance with documented procedures and all inspection and production run reports were documented as acceptable.The catheter parts utilized to produce the product were inspected at incoming and met specification requirements.There were no discrepancies or deviations that could be related to a defect with the balloon not deflating properly.It was confirmed that the user stated that this event was an operator error since they forgot to deflate the balloon before removing the administration set.Most recent follow-up information received from bracco uk on (b)(6) 2019 and from bracco group quality on (b)(6) 2019.Information processed together as a combined follow-up report, incorporated above, includes: investigation results and root cause have been provided.Outcome: recovering.This case is medically closed.Corresponding worldwide case id# (b)(6).

• Brand Name: PROTOCOL TOUCH
• Type of Device: PROTOCOL TOUCH
• Manufacturer (Section D): BRACCO DIAGNOSTICS INC; 155 pinelawn road; suite 230n; melville NY 11747
• MDR Report Key: 9186333
• MDR Text Key: 207001037
• Report Number: 2411512-2019-00006
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SN390305-5158
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR