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

Catalog Number	C-PCS-830-LOCK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
The international customer reported during the use of the lock pericardiocentesis catheter set, using the seldinger technique for drain placement to drain fluid in left lower quadrant.The customer stated they no this is considered as off label.The straw colored fluid was drained on first pass of needle at five centimeters (cm).Dilation was done and allowed to drained catheter over wire.It was reported on attempt to remove wire, there was significant resistance noted and the wire appeared to be shearing.The drain was removed completely and no wire remained in situ was confirmed by abdominal ultrasound.It was reported the product was used for this procedure many times without adverse effect, and agreed it may have been user error.The patient did not experience any adverse effects due to this occurrence.The customer reported the device is available for return, but has not been received for evaluation as of the date of this report.
Additional Manufacturer Narrative
Investigation - evaluation: the device was returned in a used and damaged condition.The safety wire had separated from the distal weld and protruded from the coils.Additionally some offset coils were noted.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.The root cause is likely to be product use related, specifically not following instructions.This set is meant to remove fluid from the pericardial sac, but the customer used it in the lower left quadrant.Additionally, the aspiration was started while the wire guide was still within the catheter.The attached ifu states that this set is intended to remove fluid from the pericardial sac, and to remove the wire guide before aspirating.There was no reported difficulty with the wire guide until the aspiration began, so it is likely that this step caused the cascade of problems affecting the device.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
No additional information was reported since the submission of the initial report on 03/28/2018.

• Brand Name: LOCK PERICARDIOCENTESIS CATHETER SET
• Common Device Name: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7377264
• Report Number: 1820334-2018-00426
• Device Sequence Number: 13959044
• Product Code: GBX
• UDI-Device Identifier: 00827002024335
• UDI-Public: (01)00827002024335(17)200801(10)8110324
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: C-PCS-830-LOCK
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/28/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 70