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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem 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.
Additional 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.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.
Additional 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 #2021898-2017-00223 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.
Additional 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
• Common Device Name: CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS)
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6514827
• Report Number: 2021898-2017-00222
• Device Sequence Number: 16171955
• Product Code: NHC
• UDI-Device Identifier: 10827002441306
• UDI-Public: 10827002441306
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K071640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/18/2018
• Device Catalogue Number: 50318
• Device Lot Number: 7025160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Initial Date Received by Manufacturer: 03/23/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 05/22/2017
• Initial Report FDA Received Date: 04/22/2017
• Supplement Report FDA Received Date: 05/25/2017; 06/01/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 24 YR