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

Catalog Number	HNBR5.0-35-65-P-NS-RIM
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/10/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
A (b)(6) male patient, who has a long standing history of claudication and pvd was admitted into the ccl for angioplasty +/- stenting to the left sfa.Right groin access was achieved using the selidinger technique and the 6f sheath (another manufacturer) was inserted to commence the angiography.The 5f cook beacon tip catheter was inserted over the another manufacturer's wire and diagnostic angiography was performed using the beacon tip catheter.Angiography images showed that the patient had a proximal sfa lesion just below the profunda.When the physician attempted to remove the beacon tip catheter from the patients groin so he could introduce the interventional products to treat the sfa lesion, it was noted that the tip of the beacon tip catheter had detached from the main body and it was now dislodged in the patients left common iliac artery.Numerous attempts were made to retrieve the dislodged tip of the catheter.The 6f sheath (another manufacturer) was exchanged for a 7f.Destination and they used various snares, forceps and techniques to remove the catheter tip.After 2 hours of attempting to remove the broken tip, the physician decided to "trap" the catheter tip within the artery using another manufacturers device.This was achieved successfully.The patient then went on to have his sfa repaired used a cook zilver des 6x40 and a post dilatation with another manufacturer's balloon.The patients groin was closed with another manufacturers device and he's now recovering on the ward with no further incidents and good pulses in his left foot.
Additional Manufacturer Narrative
(b)(4).Investigation/evaluation: during the course of the investigation, a review of the complaint history, quality control, device history record, instructions for use (ifu), documentation, and specifications and a visual inspection and functional test of the returned used and damaged product was conducted.One used device, 19 unused devices, and 5 unused devices from another lot were returned for investigation.The tip of the used device was not returned for investigation.Visual inspection confirmed circumferential separation of the tip 4mm distal of the bond joint.No elongation was noted at the point of separation.Microscopic images showed signs of material degradation.One unused device was functionally tested by subjecting the tip to forces it may experience in a clinical setting, specifically, bending.This catheter was manually pulled and showed some signs of elongation.This catheter separated at 6mm distal of the bond joint.One unused device from another lot was also functionally tested by subjecting the tip to forces it may experience in a clinical setting.This catheter was not manually pulled, but rather pulled on the instron tensile tester.Based on functional testing and visual inspection the used product and 19 unused products are confirmed for material degradation.The 5 unused products do not show any signs of material degradation.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, "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.We will continue to monitor for similar complaints and have notified the appropriate internal personnel.
Event or Problem Description
A (b)(6) male patient, who has a long standing history of claudication and pvd was admitted into the ccl for angioplasty +/- stenting to the left sfa.Right groin access was achieved using the selidinger technique and the 6f sheath (another manufacturer) was inserted to commence the angiography.The 5f cook beacon tip catheter was inserted over the another manufacturer's wire and diagnostic angiography was performed using the beacon tip catheter.Angiography images showed that the patient had a proximal sfa lesion just below the profunda.When the physician attempted to remove the beacon tip catheter from the patients groin so he could introduce the interventional products to treat the sfa lesion, it was noted that the tip of the beacon tip catheter had detached from the main body and it was now dislodged in the patients left common iliac artery.Numerous attempts were made to retrieve the dislodged tip of the catheter.The 6f sheath (another manufacturer) was exchanged for a 7f.Destination and they used various snares, forceps and techniques to remove the catheter tip.After 2 hours of attempting to remove the broken tip, the physician decided to "trap" the catheter tip within the artery using another manufacturers device.This was achieved successfully.The patient then went on to have his sfa repaired used a cook zilver des 6x40 and a post dilatation with another manufacturer's balloon.The patients groin was closed with another manufacturers device and he's now recovering on the ward with no further incidents and good pulses in his left foot.

• 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: 5541572
• Report Number: 1820334-2016-00138
• Device Sequence Number: 11003819
• Product Code: DQO
• UDI-Device Identifier: 00827002084445
• UDI-Public: (01)00827002084445(17)170818(10)5200941
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2016

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 Catalogue Number: HNBR5.0-35-65-P-NS-RIM
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/10/2016
• Device Age: 20 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/01/2016
• Supplement Report FDA Received Date: 10/11/2016
• 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: Z-2610-2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR