MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY VENTRICLEAR II VENTRICULAR DRAINAGE CATHETER SET WITH COOK SPECTRUM ANTIBIOTIC; CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS)

Catalog Number 50318

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 03/17/2017

Event Type  Injury  

Manufacturer Narrative

The product was unavailable for return as it was discarded at the facility.Therefore an evaluation of the device performance was not possible.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.

Event Description

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.

Manufacturer Narrative

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.

Manufacturer Narrative

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 #2021898-2017-00222 and #2021898-2017-00223 for details regarding the other two events.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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: VENTRICLEAR II VENTRICULAR DRAINAGE CATHETER SET WITH COOK SPECTRUM ANTIBIOTIC
• Type of Device: CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS)
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis,mn, CA 55432 ; 7635260594
• MDR Report Key: 6514826
• MDR Text Key: 73453919
• Report Number: 2021898-2017-00224
• Device Sequence Number: 1
• Product Code: NHC
• UDI-Device Identifier: 10827002441306
• UDI-Public: 10827002441306
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2018
• Device Catalogue Number: 50318
• Device Lot Number: 7025160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24 YR