MAUDE Adverse Event Report: COOK INC COPE STAINLESS STEEL MANDRIL WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number N/A

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/05/2018

Event Type  Injury  

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 Description

The international customer reported that after the initial access was established during a percutaneous transhepatic cholangiography procedure, while manipulating the cope stainless steel mandril wire guide , approximately two centimeters of the distal tip broke and could not be retrieved, despite several attempts.The end of the wire remained inside the patient and there are no plans currently to remove the piece.Additional details regarding the incident have been requested from the customer.The complaint product is reportedly unavailable for return; however, an unused device of the same lot is available.As of the date of this report, no device has yet been received for evaluation.

Manufacturer Narrative

The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Manufacturer Narrative

Investigation ¿ evaluation a review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, trends of the device and visual inspection/dimensional verification of sample devices were conducted during the investigation.The complaint device was not returned; however, 5 unused devices from the product lot were returned for investigation.The diameter of all the guides was within specifications, and there was no damage found to the solder connections or the surface of the guide.The tip shapes were all within specifications.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The quality control documents and manufacturing instructions were reviewed and there are adequate quality controls in place to ensure the device is manufactured to specifications.The device history record was reviewed and no non-conformances were found associated with lot 8234979.Also, a search of the manufacturer's complaint database revealed no additional complaints have been reported from lot 8234979.The caution label affixed to the wire guide holder warns against removal from a needle and manipulation of the guide, as damage may occur.Based on the information provided and the results of our investigation, the probable root cause was determined to be user technique.We will continue to monitor for similar complaints and will notify appropriate personnel.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.H3 other text : blank fields on this form indicate the information is previously submitted, unknown, or unavailable.

• Brand Name: COPE STAINLESS STEEL MANDRIL WIRE GUIDE
• Type of Device: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7298061
• MDR Text Key: 100999149
• Report Number: 1820334-2018-00414
• Device Sequence Number: 1
• Product Code: DXQ
• UDI-Device Identifier: 00827002051775
• UDI-Public: (01)00827002051775(17)221016(10)8234979
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PMG-18-60-COPE
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NEFF PERCUTANEOUS ACCESS SET.
• Patient Outcome(s): Other