MAUDE Adverse Event Report: COOK INC

Device Problem Material Puncture/Hole (1504)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Suspect medical device: exact rpn of complaint device is unknown but the device was reported to be a "3fr silicone catheter".Common device name: not available as the exact complaint device rpn is unknown, however other 3 fr cook catheters have procodes foz and ljs.Pma/510(k): not available as the exact complaint device rpn is unknown, however other 3 fr cook catheters have pma/510(k) #¿s of k950118 and k111244.The device was removed.It is currently unknown if the device was replaced.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 that a hole was found in the silicone catheter of an unknown cook 3fr picc device less than 24 hours after placement.The hole was located just below the device's hub, but not in the line itself.The device was ultimately removed.Additional information regarding the patient, device, and event has been requested but is currently unavailable.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation it was reported by arkansas children hospital that a cook 3 fr silicone catheter had a hole in it less than 24 hours after placement.The line had to be removed.The hole wasn't in the line itself.Attempts to acquire additional information from the user facility were executed; however, no additional information was provided to cook in response to this incident.A review of the instructions for use (ifu) and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) was unable to be completed due to a lack of lot information from the user facility.Based on sales to the user facility dating from 2017 to current, the device was able to be narrowed down to two possibilities, pics-301-mpis (silicone peripherally inserted central venous catheter) or pics-301-mpis-nt (silicone peripherally inserted central venous catheter).As no objective evidence is available for the device, it is assumed the device is one of the two identified for the purpose of the investigation.As adequate inspection activities have been established and no lot related information is available, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The current ifu supplied with the silicone peripherally inserted central venous catheter includes the following in relation to the reported failure mode: ¿warnings -silicone peripherally inserted central venous catheters are not designed for power injection of contrast medium.Catheter rupture may occur.Use of a 10ml or larger syringe will reduce the risk of catheter rupture.Precautions -if lumen flow is impeded, do not force injection or withdrawal of fluids.Notify attending physician immediately.Catheter placement (fluoroscopic method) 15.After catheter is final position, remove obturator, secure catheter to skin and dress in standard fashion catheter placement (fluoroscopic method)¿ based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be established.Due to limited information, factors such as manufacturing, component failure, patient activity, associated device use, and clinical use could not be ruled as possible contributing factors.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10626746
• MDR Text Key: 212088189
• Report Number: 1820334-2020-01805
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Date Manufacturer Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1