MAUDE Adverse Event Report: COOK INC TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(b)(4).This case was reviewed by outside professional clinical review.The event is currently under investigation.
Event or Problem Description
It was reported during a transjugular biopsy (bx) procedure the 7fr sheath fractured at the distal tip while gaining access through the right hepatic vein in the liver of a tortuous anatomy.(180334-2016-01148).The fracture of the sheath led to both the memory polyp baskets (mpb) and another manufacturers glide catheter distal tips being sheared off and remaining in the patient, the glide catheter was retrieved using a snare.The cook mpb was located in the pulmonary artery and unable to be retrieved.(1820334-2016-01149).The decision was made to leave the piece of mpb catheter inside the patient anatomy, as it currently does not appear to pose serious risk to the patient.Furthermore, attempts to retrieve were determined to possibly yield a greater risk then leaving it as is.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the device history record, documentation, instructions for use (ifu), specifications, quality control and visual inspection of the returned device was conducted during the investigation.This product was shipped with an ifu, which states under precautions: "due to thin wall construction, extreme care must be exercised during manipulation and withdrawal.Catheter insertion through a synthetic vascular graft should be avoided whenever possible." it also states, ¿the possible whiplash effect of the long, soft catheter tip must be considered during selective angiography." the device history record was reviewed and two non-conformances were noted in the production department.A review of the non-conformance data revealed that the non-conformance listed on the device history record was for tip damage and bond separation.These non-conformances were not related to the reported failure.The affected product was returned to assist in the investigation.Visual examination of the complaint photos show the distal end is separated from the catheter.The catheter also appears to have blood matter on it.Additionally, a slight elongation was noted in the tip material.The distal tip was not returned to assist in this investigation.It was reported that the patient anatomy was heavily calcified.Based on the available information the exact cause of the issue is not clear.The results of this investigation are inconclusive.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.Per the risk assessment no further action is required.

• Brand Name: TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
• Common Device Name: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6038005
• Report Number: 1820334-2016-01149
• Device Sequence Number: 1078891
• Product Code: DQO
• UDI-Device Identifier: 00827002096318
• UDI-Public: (01)00827002096318(17)190630(10)7074775
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: HNB5.0-38-80-P-NS-MPB
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2016
• Supplement Report FDA Received Date: 03/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 52