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 2019-02-27 for ANGIODYNAMICS / SMART PORT H787CT80STPD0 manufactured by Angiodynamics.
[137292903]
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 smartport product family and the failure mode "patient injury. " no adverse trend was indicted. In addition, this is the only reported complaint for this failure mode in the past 15 months for the smartport ct product family. The catheter is attached to the port by the end user following instructions supplied in the directions for use. The root cause of the patient pain and swelling issue has been determined to have been a component (locking collar) of the port/catheter assembly which was left behind by the end user hospital when the port was explanted. The notes from the port explantation indicate that the port was removed "intact. " repeated inquiries to the complaint reporter regarding the diagnosis of pulmonary embolism (pe) have gone unanswered. The blue boot connector being retained in the port pocket of the patient is not believed to have contributed to the pe. ((b)(4)).
Patient Sequence No: 1, Text Type: N, H10
[137292904]
On (b)(6) 2018 8fr sg lumen smart port ct was implanted on the right chest. Patient complained of pain at chest port site. The right chest smart port was explanted on (b)(6) 2018. New port was implanted on the left chest on (b)(6) 2018. Patient was discharged. Patient presented in the er on (b)(6) 2018. Patient was diagnosed with acute pulmonary emboli with symptoms of right upper extremity pain and swelling. It determined that a piece of the port assembly (the locking collar) had been retained within the patient. The retained piece was located in the tunneled site, palpable and was visible under ct scan. When the original port had been removed on (b)(6), it was "documented as intact. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317056-2019-00040 |
| MDR Report Key | 8374855 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-27 |
| Date of Report | 2019-02-27 |
| Date of Event | 2018-09-03 |
| Date Mfgr Received | 2019-02-01 |
| Device Manufacturer Date | 2018-05-31 |
| Date Added to Maude | 2019-02-27 |
| 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 / SMART PORT |
| Generic Name | PORT & CATHETER, IMPLANTED |
| Product Code | LJT |
| Date Received | 2019-02-27 |
| Catalog Number | H787CT80STPD0 |
| Lot Number | 5344453 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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; 2. Required No Informationntervention | 2019-02-27 |