MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DISPOSABLE SUBCUTANEOUS CATHETER PASSER, 38CM; CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TERM

Catalog Number 48407

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/08/2015

Event Type  malfunction  

Manufacturer Narrative

The product was not returned.Therefore an evaluation of device performance was not possible.A review of the manufacturing records showed no anomalies.(b)(4).

Event Description

It was reported to medtronic neurosurgery that the tip of the catheter passer was damaged during the procedure, and the broken part remained in the patient's body.According to the report, the physician determined that the broken piece did not pose a risk to the patient and was not likely to result in injury.Reportedly, the patient is currently under follow-up.

Manufacturer Narrative

The catheter passer was returned.The proximal end of the obturator tip was broken off.The break had an uneven, jagged edge.It is unknown how or when this damage occurred.The instructions for use that accompany the device caution ¿subcutaneous catheter passers can break at welds or component assembly points, or due to extreme deformation of the malleable shaft.A review of the manufacturing records showed no anomalies.(b)(4).

Manufacturer Narrative

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

• Brand Name: DISPOSABLE SUBCUTANEOUS CATHETER PASSER, 38CM
• Type of Device: CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TERM
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: jeffrey henderson ; 125 cremona drive; goleta, CA 93117 ; 8055718445
• MDR Report Key: 5138618
• MDR Text Key: 28075605
• Report Number: 2021898-2015-00394
• Device Sequence Number: 1
• Product Code: MAJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K911382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 48407
• Device Lot Number: D55640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2014
• 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