MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported foreign matter was found in the packaging of an ultrathane mac-loc locking loop biliary drainage catheter outside of manufacturer distribution.The product did not make patient contact or affect the scheduling of any procedures.
Additional Manufacturer Narrative
Correction: investigation - evaluation: a review of the complaint history, device history record, quality control, as well as a review of photos of the device provided by the customer was conducted during the investigation.The customer was unable to return the complaint device for investigation.However, an examination of complaint device photos confirmed the presence of foreign matter in the outer pouch of the sealed device package.As a result, the device was found to be out of specification per quality control documents for foreign matter in outer pouch.Additionally, a document based investigation evaluation was performed.Based on the review of current documentation, sufficient controls and inspections are in place to prevent the release of nonconforming product related to the reported failure mode.A review of the device history record showed no relevant nonconformances that could have contributed to the reported failure mode.It should be noted that there have been no other complaints reported for lot 9026746 or similar device lots.Based on the information provided, examination of product photos and the results of our investigation, a definitive root cause can be traced to manufacturing and a quality control deficiency.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.
Event or Problem Description
No new event description information to report at this time.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
• Common Device Name: GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8130396
• Report Number: 1820334-2018-03666
• Device Sequence Number: 11155315
• Product Code: GCA
• UDI-Device Identifier: 00827002094994
• UDI-Public: (01)00827002094994(17)210718(10)9026746
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2018

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: Other
• Device Expiration Date: 07/18/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT12.0-38-40-P-32S-CLB-RH
• Device Lot Number: 9026746
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 12/27/2018
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 12/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1