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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device code: dqo, catheter, intravascular, diagnostic.The event is currently under investigation.
Event or Problem Description
A right ica aneurysm embolization procedure was being performed on the (b)(6) female patient; who had a tortuous and calcified anatomy.When the catheter was placed into the right common carotid artery, it was noted that the tip had broken, but still remained intact.The user removed the catheter and changed to another of the same device from the same lot.Again, when the catheter was placed into the right common carotid artery, the tip broke again, and it also remained intact.However, as the user attempted to remove the catheter; when it reached the introducer sheath, the tip separated and the fractured segment migrated into the sfa.The fragmented segment was removed with a snare.The anatomy of the patient was reported to have been calcified and tortuous.The user replaced this with another catheter from the same lot and completed the procedure.No information provided regarding patient outcome.
Additional Manufacturer Narrative
(b)(4).Investigation/evaluation: a review of complaint history, device history record, documentation, instructions for use (ifu), quality control and a visual inspection and functional test of the returned device were conducted during the investigation.One unused product and two used products were returned.Functional testing required excess force beyond what the catheter would experience in a clinical setting to separate the tip from the shaft.Circumferential separation occurred approximately 4 mm distal of the bond joint.Microscopic inspection shows a mixture of shaft and tip material at the separation which is indicative of a complete bond melt.The failure mode could not be replicated, this product will be considered unconfirmed.This product is in scope of a recall.This 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." additionally, the product should be "store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred." a capa has previously been opened to investigate this failure mode.This complaint will conservatively be accepted for this capa.The appropriate internal personnel have been notified, and we will continue to monitor for similar complaints.
Event or Problem Description
A right ica aneurysm embolization procedure was being performed on the (b)(6) female patient; who had a tortuous and calcified anatomy.When the catheter was placed into the right common carotid artery, it was noted that the tip had broken, but still remained intact.The user removed the catheter and changed to another of the same device from the same lot.Again, when the catheter was placed into the right common carotid artery, the tip broke again, and it also remained intact.However, as the user attempted to remove the catheter; when it reached the introducer sheath, the tip separated and the fractured segment migrated into the sfa.The fragmented segment was removed with a snare.The anatomy of the patient was reported to have been calcified and tortuous.The user replaced this with another catheter from the same lot and completed the procedure.No information provided regarding patient outcome.

• Brand Name: BEACON TIP 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: 5492488
• Report Number: 1820334-2016-00139
• Device Sequence Number: 963057
• Product Code: DQO
• UDI-Device Identifier: 00827002115170
• UDI-Public: (01)00827002115170(17)161201(10)4707756
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2016

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: HNBR5.0-38-125-P-NS-SIM2
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/18/2016
• Device Age: 2 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2016
• Supplement Report FDA Received Date: 10/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1820334-29JUN2015-002-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 60