MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 01/23/2019

Event Type  Injury  

Manufacturer Narrative

Initial reporter also sent report to fda: unknown.Pma/510(k) #: exempt.(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 an ultrathane mac-loc locking loop multipurpose drainage was placed in a patient on (b)(6) 2019.Patient was scheduled for an unrelated procedure.Staff reported, after transferring patient from the anesthesia stretcher to the operating room table, the hub of the catheter was detached from the catheter and was leaking.It is unclear if the separation occurred during transfer or prior to event.As reported, the physician replaced drain with unknown device successfully.No other adverse effects were reported for this incident.Additional information regarding the event and patient outcome has been requested but is currently unavailable.

Manufacturer Narrative

Concomitant medical products:.038 x 75 amplatz super stiff guidewire.Patient code: 3191 [no code available] - extended anesthesia and additional x-ray exposure required to replace device.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information was provided by the customer on 11feb2019.See below description for full event details.It was reported an ultrathane mac-loc locking loop multipurpose drainage was placed in a patient on (b)(6) 2019 for a nephrostomy.The patient was then scheduled for a peripheral central venous catheter (cvc) insertion three days later.The staff reported, after transferring patient from the anesthesia stretcher to the operating room table for the cvc placement, the hub of the catheter was detached from the catheter and was leaking.It is unknown if the separation occurred during transfer or prior to event.The drain was then removed over a wire and a replacement drain was inserted, requiring extended anesthesia and x-ray screening.No other adverse effects were reported for this incident.

Event Description

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

Manufacturer Narrative

D10: product received on 04apr2019.Investigation/evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), documentation as well as a visual inspection were conducted during the investigation.The complaint device was returned to aid in the investigation.A visual inspection of the device that the customer returned revealed one 8.5fr mac-loc catheter in a used and damaged condition.It was noted that the device was returned in three pieces.The first piece consisted of the mac-loc hub and connector cap.The second piece consisted of catheter tubing from the flare to a separation.The third piece consisted of catheter tubing from the separation to the distal pigtail curl.The separation was likely a cut by the complainant during device removal.Suture string was tied and knotted around the catheter tubing.We noted no other surface damage.Biomatter was present on the device.The flare appeared to have a small crease along its length, had a minor lip, and was generally well-formed.Due to the compression of the flare within the cap and the potential damage upon removal, it cannot be determined if the flare was manufactured to cook's specifications.The device was separated, but it was not out of specification for any of the attributes measured.Additionally, a document-based investigation evaluation was performed for lot 9226334 and found no relevant non-conformances.Cook concluded that only the recorded non-conformances from the similar device lots are relevant to this incident.The lots were fully inspected, and any non-conforming product was scrapped.Because all relevant non-conforming product was scrapped, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and there are no other lot-related complaints that have been received from the field, cook has concluded that there is no evidence that non-conforming product exists in house or in the field.Based on the information provided, no returned product and the results of the investigation, a definitive cause could not be established appropriate measures are being conducted to address this failure mode.The appropriate personnel have been notified.Per the quality engineering risk assessment, no further action is required.Cook will continue to monitor for similar complaints 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.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Type of Device: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8332970
• MDR Text Key: 135942625
• Report Number: 1820334-2019-00363
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00827002095014
• UDI-Public: (01)00827002095014(17)211010(10)9226334
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2019

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 Expiration Date: 10/10/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-25-P-6S-CLM-RH
• Device Lot Number: 9226334
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/28/2019
• Initial Date FDA Received: 02/12/2019
• Supplement Dates Manufacturer Received: 02/11/2019; 04/11/2019
• Supplement Dates FDA Received: 03/04/2019; 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 MO