MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-07-31 for ANGIODYNAMICS H9656062093161 manufactured by Angiodynamics.
[152761440]
A review of the device history records was performed for the indicated packaging and component lots for any deviations related to the reported defect of the complaint. The review confirms that the lots met all material, assembly and performance specifications. The recent angiodynamics complaint report was reviewed for the convenience kit and preceptor dts and manifolds product families for the failure modes "bond break/damaged" and "air bubbles. " no adverse trends were indicated. Returned for evaluation was a bonded device assembly. The male luer lock from the manifold rotating adaptor was found to be broken off where it is bonded into the female luer lock of the 10" contrast injection line. No leak testing was performed due to the condition of the sample. There did not appear to be any manufacturing defects visible on the returned bonded assembly. Based on the sample evaluation and the manufacturing process controls in place to verify correct bonding of component, possible root causes of the damage may be due to the end user trying to tighten the bonded connection, or handling damage during transit. No other damage was noted to the returned sample. The directions for use supplied to the end user with the convenience kit contains the warning: "ensure that you are making secure connections when using this device to prevent the introduction of air into the system. All connections should be finger tightened. Over tightening can cause cracks and leaks to occur. " examine product carefully for entrapped air and fully debubble prior to injection to minimize the potential for embolism. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[152761441]
As reported by hospital in the (b)(6), while using an angiographic convenience kit, " the patient has had chest pains / ischemia and st elevations after air has entered the coronary. Patient has recovered. " the device used in the reported procedure has been returned to angiodynamics for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317056-2019-00097 |
| MDR Report Key | 8845237 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-07-31 |
| Date of Report | 2019-07-29 |
| Date of Event | 2019-07-01 |
| Date Mfgr Received | 2019-07-01 |
| Device Manufacturer Date | 2019-04-10 |
| Date Added to Maude | 2019-07-31 |
| 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 | MR. LAW RYAN |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal | 12801 |
| Manufacturer G1 | ANGIODYNAMICS |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANGIODYNAMICS |
| Generic Name | CARDIOVASCULAR PROCEDURE KIT |
| Product Code | OEZ |
| Date Received | 2019-07-31 |
| Returned To Mfg | 2019-07-09 |
| Catalog Number | H9656062093161 |
| Lot Number | 5458141 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS |
| Manufacturer Address | 10 GLENS FALLS TECHNICAL PARK GLENS FALLS NY 12801 US 12801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-07-31 |