MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-07-10 for ANGIODYNAMICS H965806412421 manufactured by Angiodynamics.
[79571963]
As no lot number was provided, a ship history report (shr) was generated for item number (h965806412421) in order to ascertain the last three lots shipped to the reporting customer in the six months prior to the procedure date. The device history records for the lots obtained through the shr (packaging lots) were reviewed 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 may 2017 angiodynamics complaint report was reviewed for the pressure monitoring line product family and the failure mode "air injected. " march-0, april-0 and may-0. This does not constitute an adverse trend. The used pressure monitoring line (pml) was returned to angiodynamics. As received, the pml contained bio material {blood} inside the tubing. There was no damage or manufacturing related defects noted. In addition, a microscopic inspection was performed paying particular attention to the female luer and the male luer. A microscopic visual inspection of the female was performed for any damage, and it was noted that there was a slight surface crack just below the female threads. A microscopic visual inspection of the male was performed for any damage, and it was noted that there was a slight surface crack just below the male threads. The surface cracks noted, did not extend to the inside of the fittings. The male and female tapers as well as the female threads were measured and found to be within specification. Leak testing was then performed on the device, and it passed testing. The reported complaint description cannot be confirmed as the returned sample was evaluated and was found visually, dimensional and functionally acceptable. It is possible that the end user did not fully secure the connections on each end of the pml, thereby allowing air to enter the system. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[79571964]
As reported by angiodynamics' distributor in (b)(6), "during an angio procedure, images were taken on the left sided arteries. The catheter was changed, aspirated back, and tested with no issues. Once engaged into the rca, images were taken and multiple bubbles injected down artery due to crack occurring at end of extension tubing that connects to 3-way tap. " it was also stated that, "the patient did not suffer any adverse effects. " the used pressure monitoring line was returned to angiodynamics for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317056-2017-00051 |
| MDR Report Key | 6698912 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-07-10 |
| Date of Report | 2017-07-10 |
| Date of Event | 2017-05-24 |
| Date Mfgr Received | 2017-06-19 |
| Date Added to Maude | 2017-07-10 |
| 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 Phone | 5187424488 |
| 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 | PRESSURE MONITORING LINE |
| Product Code | DRI |
| Date Received | 2017-07-10 |
| Returned To Mfg | 2017-06-26 |
| Catalog Number | H965806412421 |
| 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 | 2017-07-10 |