MAUDE Adverse Event Report: COOK INC KUMPE ACCESS CATHETER; GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 04/11/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The distal end of the (b)(4) access catheter severed during the procedure.The separated tip was recovered with a basket.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), specifications, trends, quality control and visual inspection of the returned device was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: the proper warnings, precautions, and instructions for use.Visual inspection of the returned product confirms circumferential separation approximately 3mm distal of the bond joint.Microscopic examination of the returned product shows no signs of elongation indicative of material degradation.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.We will continue to monitor for similar complaints.

Event Description

The distal end of the kumpe access catheter severed during the procedure.The separated tip was recovered with a basket.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: KUMPE ACCESS CATHETER
• Type of Device: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 5651306
• MDR Text Key: 45090239
• Report Number: 1820334-2016-00301
• Device Sequence Number: 1
• Product Code: GBL
• UDI-Device Identifier: 00827002180741
• UDI-Public: (01)00827002180741(17)170601(10)5026859
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 023565-BT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/11/2016
• Device Age: 22 MO
• Event Location: Hospital
• Date Manufacturer Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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): Required Intervention