MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-02 for PROTOCO2L AUTOMATED CO2 INSUFFLATOR CATHETER 390402, PROTOCOL ADMIN SET 390402 manufactured by E-z-em Inc...
[99789550]
Result/conclusion of the investigation: the complaint historical data shows no similar cases related to the batch involved. Company comments: during a colonoscopy ct procedure, the catheter balloon of the protoco2l colon insufflator administration set ruptured inside the patient. The patient was not aware of the incident and no injuries occurred. Investigation of this complaint is underway.
Patient Sequence No: 1, Text Type: N, H10
[99789651]
On 03-jan-2018: initial device case was received from a nurse via the (b)(6) at (b)(6) and forwarded to (b)(4) (operating on behalf of bracco) on the same day. On 19-jan-2018, live follow up for this case was received from a health professional at bracco (b)(4) ltd and forwarded to (b)(4) on the same day. All information was included in the initial report. The health authority and a health professional report: a female patient of unknown age underwent a computerised tomography (ct) colonoscopy procedure for an unknown indication with the use of a small catheter and retention cuff co2 delivery system for colon insufflation (protoco2l admin set (catalogue number 390402, serial number (b)(4), batch number 60035905 (6407), system model number 390402)) on (b)(6) 2017. During the colonoscopy procedure, a pop was heard from inside the patient. No air was able to be withdrawn from the catheter balloon. The prone scan was checked and there was no evidence of the balloon on the images. On withdrawal of the catheter, the balloon was checked and had ruptured, but all parts of the balloon were present. The catheter balloon had been checked, inflated and deflated, prior to the insertion into the patient. The catheter was disposed in the clinical waste as it was heavily contaminated with faecal matter. No injury occurred to the patient. The patient was monitored for an unknown time for any further problems. Patient was unaware of the incident. The complaint history data shows no similar cases related to the batch involved. A expedited investigation has been initiated with trackwise id (b)(4). Outcome: recovered/resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411512-2018-00001 |
| MDR Report Key | 7236523 |
| Date Received | 2018-02-02 |
| Date of Report | 2018-01-03 |
| Date of Event | 2017-12-20 |
| Date Mfgr Received | 2018-02-27 |
| Date Added to Maude | 2018-02-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PATRICE MARCHILDON |
| Manufacturer Street | 155 PINELAWN ROAD SUITE 230N |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal | 11747 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROTOCO2L AUTOMATED CO2 INSUFFLATOR CATHETER |
| Generic Name | SMALL CATHETER AND RETENTION CUFF CO2 |
| Product Code | FCX |
| Date Received | 2018-02-02 |
| Model Number | 390402, PROTOCOL ADMIN SET |
| Catalog Number | 390402 |
| Lot Number | 60035905 (6470) |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | E-Z-EM INC.. |
| Manufacturer Address | 155 PINELAWN ROAD SUITE 230N MELVILLE NY 11747 US 11747 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-02 |