MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2017-04-22 for VENTRICLEAR II VENTRICULAR DRAINAGE CATHETER SET WITH COOK SPECTRUM ANTIBIOTIC 50318 manufactured by Medtronic Neurosurgery.
[73453505]
The product testing is in progress. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[73453506]
It was reported to medtronic neurosurgery that a physician stated the catheter broke off during a procedure during insertion. According to the report, the catheter popped off/snapped while in the patient during the procedure. Reportedly, the patient experienced pneumocephalus. Per the surgeon, the current status of the patient was fine and they had returned to baseline.
Patient Sequence No: 1, Text Type: D, B5
[76209690]
Additional information received reported that due to the catheter breaking, the surgeon was delayed in relieving the intracranial pressure of the brain and the patient developed pneumocephalus. According to the report, a different manufacturer? S catheter was used. It was noted that some breakage happened after the catheter had been sutured in the ventricles of the patient? S brain. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[76776618]
Additional information received reported that no unintended section of the catheter remained inside of the patient's body and no additional procedures were required due to the reported event. This reported event is 1 of 3 similar events. Please refer to manufacturer reports #2021898-2017-00223 and #2021898-2017-00224 for details regarding the other two events. The catheter was returned in two pieces of lengths 20 cm and 12 cm respectively. Both edges at tear site appeared to be jagged. It is unknown how or when the damage occurred. The returned segments were patent and passed leak testing when tested individually. Proteinaceous debris was observed within the interior and exterior of the catheter. A review of the manufacturing records for the supplied catheter showed no anomalies. All supplied catheters are 100% inspected at the time of manufacture.
Patient Sequence No: 1, Text Type: N, H10
[94226709]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021898-2017-00222 |
| MDR Report Key | 6514827 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2017-04-22 |
| Date of Report | 2017-03-23 |
| Date of Event | 2017-03-17 |
| Date Mfgr Received | 2017-05-22 |
| Date Added to Maude | 2017-04-22 |
| 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 | STACY RUEMPING |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS,MN CA 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635260594 |
| Manufacturer G1 | MEDTRONIC NEUROSURGERY |
| Manufacturer Street | 125 CREMONA DRIVE |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93117 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENTRICLEAR II VENTRICULAR DRAINAGE CATHETER SET WITH COOK SPECTRUM ANTIBIOTIC |
| Generic Name | CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS) |
| Product Code | NHC |
| Date Received | 2017-04-22 |
| Returned To Mfg | 2017-04-10 |
| Catalog Number | 50318 |
| Lot Number | 7025160 |
| Device Expiration Date | 2018-05-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROSURGERY |
| Manufacturer Address | 125 CREMONA DRIVE GOLETA CA 93117 US 93117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-22 |