MAUDE Adverse Event Report: COOK, INC. SLIP-CATH BEACON TIP HYDROPHILIC ANGIOGRAPHIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number SCBR4.0-38-100-P-NS-DAV

Device Problem Tip breakage (1638)

Patient Problem Foreign body, removal of (2365)

Event Date 05/20/2014

Event Type  Injury  

Event Description

During a peripheral leg revascularization procedure in a very calcified distal superior femoral artery, the interventional radiology wanted to pull out catheter; however, it was stuck.The catheter tore off at proximal joint (1820334-2014-00253).The distal tip tore off as well and was successfully removed from the superior femoral artery by applying suction in the introducer, already in place (1820334-2014-00657).There was no harm to the pt.The procedure continued after from a new puncture in the opposite femoral.The dave radiopaque tip remained in the distal superior femoral artery for a few minutes and was successfully retrieved by applying suction in the introducer that was then partially pulled out from the puncture site and clipped to maintain the dave tip in introducer and out of the body until the end of procedure.Pt had to be punctured ipsilateral to finish procedure.

Manufacturer Narrative

(b)(4).Two products were returned in an opened and used condition along with two products; which were returned unused.During investigation, the following was conducted: reviews of complaint history, ifu, qc, and a visual inspection.The visual inspection noted that the proximal fitting had separated from the catheter (1820334-2014-00253).Upon completion investigation for the fitting separation, it was determined that another report should be opened as a result of the separation at the distal tip (1820334-2014-00657).Per quality control specification, fittings should be free of damage and debris.It is visually verified that the tubing is advanced into adapter and that there is no gap between tubing and funnel.This product is shipped with an ifu; which states under precautions: "due to thinwall construction, extreme care must be exercised during manipulation and withdrawal"."the possible whiplash effect of the long, soft catheter tip must be considered during selective angiography".The pt event info stated that: "during a peripheral leg revascularization procedure in a very calcified distal superior femoral artery, the interventional radiology wanted to pull out catheter; however, it was stuck.The catheter tore off at proximal joint.The distal tip tore off as well and was successfully removed from the superior femoral artery by applying suction in the introducer, already in place".Pulling the catheter out of the calcified sfa leading to the catheter being exposed to tensile forces beyond its may have led to this failure mode.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Quality engineering risk assessment was used to assess this complaint.Per the conclusion, no further risk reduction is required.

• Brand Name: SLIP-CATH BEACON TIP HYDROPHILIC ANGIOGRAPHIC CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4335992
• MDR Text Key: 5178261
• Report Number: 1820334-2014-00657
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K122937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2016
• Device Catalogue Number: SCBR4.0-38-100-P-NS-DAV
• Device Lot Number: 4605606
• Other Device ID Number: (01)00827002310049(17)161101(1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/03/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/20/2014
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 11/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention