MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-03-23 for CELLEBRITY? M00516071 1607 manufactured by Boston Scientific - Spencer.
[40959015]
(b)(4) according to the complainant, the suspect device has been disposed and is not available for return. If any further relevant information is received, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[40959016]
It was reported to boston scientific corporation that a cellebrity cytology brush was opened for use during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2016. According to the complainant, during unpacking, the brush detached from the rest of the device. The procedure was completed with another cellebrity cytology brush. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be stable.
Patient Sequence No: 1, Text Type: D, B5
[45104403]
Visual analysis of the returned rx cytology brush found that the catheter was kinked from the distal end of the strain relief and had been flattened or stretched. The pull wire was not present inside the handle and was pulled out of the handle spool. The wire was extended out of the distal sheath and the exposed section of the wire had been bent and kinked. When wire was removed from the sheath, it was found that the wire had been bent from the handle cannula. The tip of the brush was missing and was not returned. The condition of the distal tip of the wire was consistent with the wire having been cut. The complaint was confirmed; the returned device condition indicates the device was subject to force that caused the handle cannula to pull out of the handle spool, and the condition of the distal end of the brush wire indicates it was most likely cut by the user. Therefore, the most probable root cause classification for the reported failure is handling damage. A review of the device history record (dhr) was performed and no deviations were found.
Patient Sequence No: 1, Text Type: N, H10
[45104404]
It was reported to boston scientific corporation that a cellebrity cytology brush was opened for use during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2016. According to the complainant, during unpacking, the brush detached from the rest of the device. The procedure was completed with another cellebrity cytology brush. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2016-00689 |
| MDR Report Key | 5519588 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-03-23 |
| Date of Report | 2016-02-26 |
| Date of Event | 2016-02-22 |
| Date Mfgr Received | 2016-04-15 |
| Device Manufacturer Date | 2015-11-06 |
| Date Added to Maude | 2016-03-23 |
| 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 | 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 | CELLEBRITY? |
| Generic Name | BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID) |
| Product Code | BTG |
| Date Received | 2016-03-23 |
| Returned To Mfg | 2016-03-30 |
| Model Number | M00516071 |
| Catalog Number | 1607 |
| Lot Number | 18601130 |
| Device Expiration Date | 2017-11-30 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - SPENCER |
| Manufacturer Address | 780 BROOKSIDE DRIVE SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-23 |