MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-19 for QUANTUM TTC ESOPHAGEAL BALLOON DILATOR QD-14X8 manufactured by Cook Endoscopy.
[184170561]
Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report. A functional test was performed and the balloon was attempted to be inflated with water using a cook ds-60cc-s dilation syringe. The balloon could not be inflated and a leakage was observed from a rupture in the balloon material. A visual examination showed a rupture from the center of the balloon material to the proximal end of the balloon. The catheter did not show any kinks or bends. No portion of the device appeared to be missing. A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis. The device history record does contain a nonconformance that could potentially be related to the complaint. The device goes through different inspections prior to leaving the facility. These inspections would have removed any nonconforming devices prior to distribution. Investigation conclusion: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting. Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis. This limits our ability to conclusively determine a cause. A possible contributing factor for leakage is if the device comes in contact with a sharp object or burr in the endoscope accessory channel. Also, the responses to additional questions indicate that it is not known what device was used to inflate the balloon. Another possible contributing factor is using a compromised inflation device to inflate the balloon. If the pressure reading of the inflation device is inaccurate, this could contribute to over inflation, possibly resulting in damage to the balloon material. Prior to distribution, all quantum ttc esophageal balloon dilators are subjected to a leak test to ensure device integrity. Corrective action: corrective action is not warranted at this time based on the quality engineering risk assessment. Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
Patient Sequence No: 1, Text Type: N, H10
[184170562]
During an esophagogastroduodenoscopy (egd), the physician used a cook quantum ttc esophageal balloon dilator. The patient aspirated after they attempted to inflate the balloon. The balloon was found to be leaking. A section of the device did not remain inside the patient? S body. The patient required antibiotics and breathing treatment due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence. The patient did well after the breathing treatment and antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037905-2020-00150 |
| MDR Report Key | 9855893 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-19 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2018-12-27 |
| Date Added to Maude | 2020-03-19 |
| 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 | MS. SCOTTIE FARIOLE |
| Manufacturer Street | 4900 BETHANIA STATION RD |
| Manufacturer City | WINSTON-SALEM NC 27105 |
| Manufacturer Country | US |
| Manufacturer Postal | 27105 |
| Manufacturer Phone | 3367440157 |
| Manufacturer G1 | COOK ENDOSCOPY |
| Manufacturer Street | 4900 BETHANIA STATION RD |
| Manufacturer City | WINSTON-SALEM NC 27105 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27105 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUANTUM TTC ESOPHAGEAL BALLOON DILATOR |
| Generic Name | KNQ, DILATOR, ESOPHAGEAL |
| Product Code | KNQ |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-03-10 |
| Catalog Number | QD-14X8 |
| Lot Number | W4158655 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK ENDOSCOPY |
| Manufacturer Address | 4900 BETHANIA STATION RD WINSTON-SALEM NC 27105 US 27105 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-19 |