MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-31 for AMPLATZ TYPE GRADUATED RENAL DILATATION SET M0062601000 260-100 manufactured by Boston Scientific - Marlborough.
[76502814]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[76502815]
It was reported to boston scientific corporation that an amplatz renal dilator set was unpacked on an unknown date. According to the complainant, there were debris found inside the sterile packaging. It was noted that the device sterile seal was intact before being opened and there were no damages noticed on the outer packaging. There was no procedure and patient involved.
Patient Sequence No: 1, Text Type: D, B5
[80145978]
A visual examination of the returned dilator/sheath set revealed that the upper section of the pouch is completely open. It was also noticed that a foreign material in the upper section of the pouch (inside the pouch), likely the foreign material was held by the customer with a kind of adhesive tape. The devices and plastic tray do not present any visual issue. Therefore, the condition of the returned device confirms the reported event. As the device was received with the packaging having already been opened, the root cause as to where and when the foreign material got there with the packaging is undetermined. Given the event description and condition of the returned device, there isn't enough information to determine a probable root cause. A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications. A search of the complaint database revealed that no other complaints exist for the specified lot.
Patient Sequence No: 1, Text Type: N, H10
[80145979]
It was reported to boston scientific corporation that an amplatz renal dilator set was unpacked on an unknown date. According to the complainant, there were debris found inside the sterile packaging. It was noted that the device sterile seal was intact before being opened and there were no damages noticed on the outer packaging. There was no procedure and patient involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2017-01541 |
| MDR Report Key | 6601036 |
| Date Received | 2017-05-31 |
| Date of Report | 2017-05-09 |
| Date Mfgr Received | 2017-06-01 |
| Device Manufacturer Date | 2015-09-29 |
| Date Added to Maude | 2017-05-31 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EMP. NANCY CUTINO |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Manufacturer G1 | BOSTON SCIENTIFIC - SPENCER |
| Manufacturer Street | 780 BROOKSIDE DRIVE |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMPLATZ TYPE GRADUATED RENAL DILATATION SET |
| Generic Name | DILATOR, CATHETER |
| Product Code | GCC |
| Date Received | 2017-05-31 |
| Returned To Mfg | 2017-05-22 |
| Model Number | M0062601000 |
| Catalog Number | 260-100 |
| Lot Number | 18439513 |
| Device Expiration Date | 2019-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-31 |