MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CATHETER PASSER, DISPOSABLE, 60 CM; CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TERM

Model Number	48409
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the catheter passer was broken.It was stated they tried to run the catheter through the aluminum passer but had no luck.The doctor had tried to attach the catheter passer onto the inner plastic sleeve (within the aluminum passer), and as positioning the catheter onto the catheter passer, the small plastic sleeve broke (part that connects the catheter) which meant the shunt catheter could not be connected to the catheter passer.The device was replaced with another one, and the issue was resolved at the time of the report.The patient's medical history was epileptic fits.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received noted that there were no outside factors that contributed to the issue.
Additional Manufacturer Narrative
The returned product was not returned with the handle attached.The operator tail was damaged.It is unknown how or when this damage occurred.The instructions for use cautions, ¿improper handling or use of instruments when implanting shunt products may result in the cutting, slitting, crushing or breaking of components.¿ no anomalies were observed during a review of the device history record.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The returned product was not returned with the handle attached.The obturator tail was damaged.It is unknown how or when this damage occurred.The instructions for use cautions, ¿improper handling or use of instruments when implanting shunt products may result in the cutting, slitting, crushing or breaking of components.¿ no anomalies were observed during a review of the device history record.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CATHETER PASSER, DISPOSABLE, 60 CM
• Common Device Name: CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TERM
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8713997
• Report Number: 2021898-2019-00239
• Device Sequence Number: 2600667
• Product Code: MAJ
• UDI-Device Identifier: 00643169466319
• UDI-Public: 00643169466319
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K911382
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/13/2019

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: 10/31/2023
• Device Model Number: 48409
• Device Catalogue Number: 48409
• Device Lot Number: E57439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 06/20/2019; 07/23/2019; 08/23/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 07/03/2019; 08/12/2019; 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 7 YR
• Patient Weight: 24