MAUDE Adverse Event Report: COOK INC POLYETHYLENE ANGIOGRAPHIC CATHETER; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 12/30/2018

Event Type  Injury  

Manufacturer Narrative

Lot information unknown.Catalog number: p7.2-38-35-p-5s-pig-hirata-011480.Initial reporter also sent report to fda: unknown.Pma/510(k) #: d013269.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported a polyethylene angiographic catheter was used in an unknown procedure on an unknown patient.As reported the catheter was found to have separated approximately 7 centimeters from the catheter hub and appeared to have been pulled off.As it was reported that the patient was in restraints, the operator suggests that the catheter could have gotten tangled with other equipment present at the time causing the separation.The patient underwent a procedure to have the remaining pieces of catheter removed.The wire guide could not be inserted into the damaged catheter, so the device was cut.The physician then inserted the wire guide into the catheter and removed the catheter from the patient.The removal procedure was completed successfully.A competitors device was successfully deployed to replace the separated complaint device.With the information provided at this time, it is unclear if the separation was due to device malfunction or because of the patient¿s condition.No other adverse effects were reported for this incident.

Manufacturer Narrative

Investigation ¿ evaluation: a review of the instructions for use (ifu), quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the shaft of the returned device was divided into 3 pieces.The smoother cut surface seemed to have been made by the operator of the device, with the catheter being cut so as to remove it from the patient¿s body easily.The point of separation was 7 centimeters away from the catheter¿s hub.Additionally, it appeared to have been wrenched off.There was a mark which seemed to have been created by something near the separation point on the non-hub side/the middle portion of the 3 pieces of the device.Due to the excessive damage to the catheter, dimensional analysis could not be carried out.Thus, it cannot be determined if the device was manufactured out of specification.Additionally a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be established.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: POLYETHYLENE ANGIOGRAPHIC CATHETER
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 8254707
• MDR Text Key: 133284502
• Report Number: 1820334-2019-00088
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 01/16/2019
• Supplement Dates Manufacturer Received: 02/19/2019
• Supplement Dates FDA Received: 02/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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