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 2016-01-29 for CLASSIC SHEATH 6FCLS-1006 manufactured by St. Jude Medical, Inc.(crm-sylmar).
[37155229]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[37155230]
It was reported that pneumothorax occurred during the implant procedure. The patient did not experience any symptoms associated with pneumothorax. A chest tube was implanted and the procedure was completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017865-2016-00574 |
| MDR Report Key | 5399641 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-01-29 |
| Date of Report | 2016-01-05 |
| Date of Event | 2016-01-05 |
| Date Mfgr Received | 2016-01-05 |
| Date Added to Maude | 2016-01-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JAIME CHAVEZ |
| Manufacturer Street | 15900 VALLEY VIEW COURT |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal | 91342 |
| Manufacturer Phone | 8184934022 |
| Manufacturer G1 | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
| Manufacturer Street | 15900 VALLEY VIEW COURT |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91342 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLASSIC SHEATH 6FCLS-1006 |
| Generic Name | CADRIOVASCULAR CATHETER SHEATH INTRODUCER KIT |
| Product Code | OEX |
| Date Received | 2016-01-29 |
| Model Number | CLS-1006 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
| Manufacturer Address | 15900 VALLEY VIEW COURT SYLMAR CA 91342 US 91342 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-01-29 |