MAUDE Adverse Event Report: COOK INC TORCON NB ADVANTAGE VAN SCHIE BEACON TIP SEEKING CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problems Tip breakage (1638); Split (2537)

Patient Problem Aneurysm (1708)

Event Date 12/04/2014

Event Type  Injury  

Event Description

As per problem statement."in the catheter vanschie 3 the tip split into fragments." during an aortic stent graft implantation procedure on a male patient with pre-existing condition of an abdominal aortic aneurysm, the tip of the vanshie 3 catheter split into fragments.The fragments were retrieved with an endovascular snare.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Manufacturer Narrative

(b)(4).Event evaluation: a review of complaint history, instructions for use (ifu), quality control and a visual examination was conducted during the investigation.One device was returned in an opened and used condition and one device in an unused condition.The visual examination of the one returned, opened and used device noted that the distal tip of the catheter had split.There is no evidence to suggest that the product was not manufactured to specifications.The product is shipped with an ifu which states under precautions: "due to thinwall construction, extreme care must be exercised during manipulation and withdrawal.Catheter insertion through a synthetic vascular graft should be avoided whenever possible." / "the possible whiplash effect of the long, soft catheter tip must be considered during selective angiography." we are unable to determine with certainty the root cause for the reported difficulty.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Quality engineering risk assessment was used to assess the risk of this complaint.The addition of this complaint does not change the conclusion that no further risk reduction is required.

Event Description

During an aortic stent graft implantation procedure on a male patient with pre-existing condition of an abdominal aortic aneurysm, the tip of the vanshie 3 catheter split into fragments.The fragments were retrieved with an endovascular snare.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

A recall expansion was initiated on (b)(6) 2015.Another recall expansion was initiated on (b)(6) 2016 for any product manufactured with the beacon tip technology.This product is in scope of the recall.(b)(4).Event evaluation: a review of complaint history, instructions for use (ifu), quality control and a visual examination was conducted during the investigation.One device was returned in an opened and used condition and one device in an unused condition.The visual examination of the one returned, opened and used device noted that the distal tip of the catheter had split.There is no evidence to suggest that the product was not manufactured to specifications.The product is 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." / "the possible whiplash effect of the long, soft catheter tip must be considered during selective angiography." we are unable to determine with certainty the root cause for the reported difficulty.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Quality engineering risk assessment was used to assess the risk of this complaint.The addition of this complaint does not change the conclusion that no further risk reduction is required.

Event Description

During an aortic stent graft implantation procedure on a male patient with pre-existing condition of an abdominal aortic aneurysm, the tip of the van schie 3 catheter split into fragments.The fragments were retrieved with an endovascular snare.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: TORCON NB ADVANTAGE VAN SCHIE BEACON TIP SEEKING CATHETER
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4434208
• MDR Text Key: 5417913
• Report Number: 1820334-2015-00040
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2017
• Device Model Number: N/A
• Device Catalogue Number: HNBR5.0-35-65-P-NS-VANSCHIE3
• Device Lot Number: 4716078
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/08/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/04/2014
• Device Age: 11 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/22/2014
• Initial Date FDA Received: 01/15/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/23/2015; 08/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention