MAUDE Adverse Event Report: COOK INC PERICARDIOCENTESIS CATHETER SET; GBX CATHETER, IRRIGATION

Model Number	N/A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that a drainage catheter was placed in the patient's pericardial to drain pericardial fluid.The three-way stopcock was connected by the physician, however, the physician could not aspirate the fluid due to a crack in the three way stop cock.Another package was opened to complete the pericardial drainage treatment.No adverse effect to the patient reported.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the dimensional verification, drawing, device history record, manufacturing instructions, quality control, trends, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the presence of two cracks in the stopcock, both of which were present at its base.Crack a was measured to be 3 mm long at the base, and extends onto the neck for 1 mm.Crack b was also on the base of the stopcock, and was on the opposite side of the neck from crack a.Crack b was measured to be 1 mm long.The stopcock failed a water leak test.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: PERICARDIOCENTESIS CATHETER SET
• Common Device Name: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5839479
• Report Number: 1820334-2016-00803
• Device Sequence Number: 10873082
• Product Code: GBX
• UDI-Device Identifier: 00827002082892
• UDI-Public: (01)00827002082892(17)190124(10)6477660
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2017

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 Model Number: N/A
• Device Catalogue Number: C-PCS-850-NDHN-031594
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/24/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/02/2016
• Supplement Report FDA Received Date: 05/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1