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 2020-02-07 for PASSPORT KIT M0062181300 218-130 manufactured by Boston Scientific Corporation.
[178194502]
(b)(4). The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[178194503]
It was reported to boston scientific corporation that a passport dilatation balloon device was used in the ureter in a procedure performed on (b)(6) 2020. According to the complainant, during the procedure, the balloon burst. It was reported that a piece of the balloon was removed from the ureter and it was also noted that the end of the balloon wire was frayed. The patient condition at the conclusion of the procedure was reported to be stable. Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00337 |
| MDR Report Key | 9682857 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-07 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-01-21 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-07-01 |
| Date Added to Maude | 2020-02-07 |
| 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 | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 500 COMMANDER SHEA BOULEVARD |
| Manufacturer City | QUINCY MA 02171 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02171 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PASSPORT KIT |
| Generic Name | DILATOR, CATHETER, URETERAL |
| Product Code | EZN |
| Date Received | 2020-02-07 |
| Model Number | M0062181300 |
| Catalog Number | 218-130 |
| Lot Number | 0024574719 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-07 |