MAUDE Adverse Event Report: COOK, INC. SLIP-CATH BEACON TIP HYDROPHILLIC ANGIOGRAPHIC CATHE4TER; DQO: CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number SCBR4.0-38-65-P-NS-KMP

Device Problem Material Separation (1562)

Patient Problem Foreign body, removal of (2365)

Event Date 07/03/2014

Event Type  Injury  

Event Description

During the procedure in a very calcified distal sfa artery, ir attempted to pull the catheter out when it became stuck.During the attempt to remove the catheter by hand, the catheter tore off at the proximal joint.The piece remaining in the pt was removed by hand.The physician stated that it is believed that excessive strength was used to pull on the catheter to remove it from the calcified lesion.According to the reporter, the pt did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Removal of foreign body is not labeled.The product was returned in an opened and used condition.A visual inspection noted that the catheter shaft had separated from the hub.The end of the catheter shaft looked slightly stretched.Quality control verifies the surface of catheter is free of damage and excess bumps or roughness.There is no evidence to suggest that the product was not manufactured to specifications.This product is shipped with an instructions for use which states under precautions: "due to thinwall construction, extreme care must be exercised during manipulation and withdrawal." the appropriate internal personnel have been notified and we will continue to monitor for similar components.Per the conclusion of quality engineering risk assessment, no further risk reduction is required.

• Brand Name: SLIP-CATH BEACON TIP HYDROPHILLIC ANGIOGRAPHIC CATHE4TER
• Type of Device: DQO: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, dir ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 3981470
• MDR Text Key: 4750855
• Report Number: 1820334-2014-00339
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/03/2014

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: 02/28/2017
• Device Catalogue Number: SCBR4.0-38-65-P-NS-KMP
• Device Lot Number: 4789601
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/17/2014
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/03/2014
• Device Age: 5 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/08/2014
• Initial Date FDA Received: 07/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2014
• 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): Other