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	10/15/2018
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 that upon opening the box, the tip at where the catheter was being inserted was not present.A new box was opened to complete the vp shunt procedure.No patient death or injury occurred.The patient's current status was okay.
Additional Manufacturer Narrative
The obturator was inside the passer shaft in the wrong configuration and the tip was missing from the tail end of the obturator.The locking tip tail and handle should be at the crimped end of the passer shaft.It is not known how or when the configuration of the obturator was changed.However, the ifu that accompanies the device instructs that, ¿the surgeon is advised to ensure that the catheter will pass through the instrument prior to beginning the procedure.The tubular shaft is malleable and may be hand-formed by the surgeon as indicated for the operative procedure.When the instrument is passed subcutaneously, the obturator must be inserted in the tubular shaft and secured into the handle by snapping the obturator¿s locking tip into position.After removal of the obturator, the catheter may be hand-fed through the lumen of the tubular shaft.¿ the tip was missing from the tail end of the obturator and the passer shaft was also bent.It is not known how or when the damage to the obturator tail tip or passer shaft occurred.The ifu also cautions that, ¿improper handling or use of instruments when implanting shunt products may result in the cutting, slitting, crushing or breaking of components.Such damage may lead to a loss of shunt integrity and necessitate premature surgical revision of the shunt system.¿ all passer shafts are 100% inspected at time of manufacture.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: 7971451
• Report Number: 2021898-2018-00501
• Device Sequence Number: 1681725
• Product Code: MAJ
• UDI-Device Identifier: 00643169466319
• UDI-Public: 00643169466319
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K911382
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

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: 03/31/2023
• Device Model Number: 48409
• Device Catalogue Number: 48409
• Device Lot Number: E45989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1