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

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: unknown.Pma/510(k) #: exempt.Investigation - evaluation: a review of the complaint history, device history record, drawing, instructions for use, manufacturing instructions, quality control, specifications, as well as a functional test, dimensional verification and visual inspection of the returned device(s) was conducted during the investigation.Inspection of unused product from the same lot was also completed.Two complaint devices, 12 open devices and 7 unopened devices were returned for evaluation.Packaging confirms the lot number to be 7716007 for all returned devices.Complaint device 1: a visual examination noted that the device was returned with the wire guide still inside the catheter, with the wire guide appearing to be lodged.Coil elongation is noted to start 3.5cm from the distal tip, with 8.5cm sticking out of the catheter.Coil elongation was also noted to start 56.5cm from the proximal end and measured 44cm in length.Flat wire was found protruding from the coil approximately 60cm from the proximal end.The safety wire was protruding 67.7cm from the proximal end and 1cm outside the coil.Complaint device 2: the device was retuned with the wire guide still inside of the catheter.When the wire guide was removed from the catheter, a visual examination noted dried blood inside the device.The tip of the catheter appears to be damaged and the distal tip of the catheter was tight when attempting to re-insert the wire guide.Of the 12 devices that were returned opened, 9 wire guides were forced into the catheters and were returned assembled.The distal tips were found to be tight when attempting to re-insert the wire guides.Of the 7 unopened devices, the catheters were unable to wire the appropriate gauge wire guide.To conclude, the tips of the catheters would not pin the appropriate pin gauge.It appears that the catheters were tipped with the wrong size tip.Additionally, a document-based investigation evaluation was performed.The risk specification for this product includes the loss of use failure mode and identifies the risk controls that are in place to mitigate the risk of this type of failure.A review of the device history record for lot 7716007 found that 129 affected units were detected to have a nonconformance, for which 100 were re-worked and 29 were scrapped.Of the nonconformance codes found, only the code for taper damage could have contributed to the alleged failure mode, however, all affected devices were scrapped.It should be noted that there were no other complaints associated with this lot number.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: once the needle is in position, remove the inner stylet (if present) from the needle.Slide the safe-t-j wire guide straightener (positioned on the distal end of the wire guide) over the "j" portion of the wire guide and seat the straightener in the hub of the needle.Insert the wire guide through the needle and advance the wire guide into the pericardial sac.Note: the wire guide should advance without resistance.Leaving the wire guide in place, remove the needle.Create a small skin incision.If a dilator is included in set, the dilator should be advanced over the wire guide and removed prior to insertion of the catheter.Introduce the catheter (with stiffening cannula, if applicable) over the wire guide and advance until the tip of the catheter is posterior to the muscle fascia.If the set contains a catheter with stiffening cannula, remove the cannula with a twisting motion, while holding the catheter and wire guide in place.Advance the catheter into the pericardium.Note: the wire guide should always extend beyond the catheter tip.Remove the wire guide.If applicable, attach the appropriate connecting tube and prepare to aspirate.Based on the information provided, examination of the returned product and the results of our investigation, a definitive root cause can be traced to manufacturing and a quality control deficiency.It was concluded that despite having no notable gaps in production or processing controls, the device aspect in question was manufactured out of specification and was not adequately inspected by quality control.A quality engineer risk assessment has recommended additional escalation.We will continue to monitor for similar complaints.
Event or Problem Description
It was reported that the wire guide of a cook pericardiocentesis catheter set was unable to be withdrawn from the catheter during an unknown procedure.The physician had to remove both the catheter and the wire guide at the same time.Additional information regarding event details have been requested, but is unavailable at this time.

• 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: 8479832
• Report Number: 1820334-2019-00828
• Device Sequence Number: 16624436
• Product Code: GBX
• UDI-Device Identifier: 00827002032828
• UDI-Public: (01)00827002032828(17)200301(10)7716007
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/03/2019

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: 03/01/2020
• Device Model Number: N/A
• Device Catalogue Number: C-PCS-850
• Device Lot Number: 7716007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1