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 Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2023

Event Type  Injury  

Event Description

It was reported that an unknown ultrathane mac-loc locking loop multipurpose drainage catheter separated.The device was required for treatment of a pneumothorax and was placed in the patient.During transfer of the patient to the bed, the catheter broke and a portion of the device was retained in the patient.As a result, the pneumothorax "expanded minimally".The following day, on (b)(6) 2023, the retained catheter piece was removed from the patient.No other adverse effects have been report for this incident.

Manufacturer Narrative

Product identifier: the exact device is currently unknown.A possible rpn was provided: g09765-ult8.5-38-45-p-6s-clm-rh.Initial reporter occupation: ir manager.Pma/510(k) #: exempt.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 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.

Event Description

The complaint device was received on 06feb2023.A preliminary device failure analysis (dfa) was performed.The dfa and photos of the returned complaint device confirmed the hub and shaft of the catheter separated.This failure is being reported under the manufacturer report # 1820334-2023-00027.In addition, the dfa also confirmed another failure, shaft separation of the catheter.The shaft separation failure will also be reported under the manufacturer report # 1820334-2023-00027.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, and unchanged.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 on 13jan2023.A photo of the drain was provided showing the catheter shaft separated from the hub.The separation occurred minutes after the drain was placed.The implanting physician stated "we rigged it to work." however, the details of the action taken to work have not been provided at this time.It is unknown how the lines were managed during the transfer of the patient to the bed or if any force was exerted on the catheter.It was clarified that no unintended section of the device remained in the patient.The drain was removed by a physician assistant the next day who reported that the patient's pneumothorax expanded initially after the catheter broke, but the patient was stable.No additional procedures were reported.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: f10: annex e, annex f, annex g, h10: annex e, annex f, annex g.Additional information: b5.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 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 or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

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 unchanged, unknown, or unavailable.Additional information: d - product identifier, d4 - rpn investigation ¿ evaluation it was reported by a representative of st.John medical center (ok, usa) on 05jan2023 that an ultrathane mac-loc locking loop multipurpose drainage catheter (rpn: ult14.0-38-25-p-6s-clm-rh; lot#: unknown) separated.The device was required for use as a chest tube and was placed in a female patient on (b)(6) 2023.The patient was reported to be ¿not well¿.After the procedure, the patient was transferred to a bed when the device separated.The device had been in place for ¿minutes¿.The patient¿s pneumothorax ¿minimally expanded¿ due to this occurrence; however, the patient remained stable.After the separation, a portion of the device remained in the patient and was ¿rigged to work¿.The following day, the remaining portion of the catheter was removed.Reviews of documentation including the instructions for use (ifu), manufacturing instructions, quality control procedures, and specifications, as well as a visual inspection and dimensional verification of the returned device, were conducted during the investigation.One 14fr ult catheter was returned from an unknown lot number in a used and damaged condition.Although the customer could not provide a complete product description, with the help of manufacturing, the device was identified as an ult14.0-38-25-p-6s-clm-rh.The ult14.0 fr catheter was returned separated from the mac-loc adaptor.Additionally, the catheter exhibited catheter shaft separation.The combined length of both sections of catheter material had a length measurement of approximately 25 cm.The catheter section distal to the tear had a length measurement of approximately 20.6 cm in length.The i.D.And o.D.Of the catheter passed dimensional requirements.The end of the catheter at the point of separation was not smooth, but rather ridged.As a result of the catheter separating, the suture string was also broken.A visual examination also confirmed a small section of the string to be wrapped around the lever of the mac-loc in a locked position.A further investigation confirmed there was no catheter material left between the cap and mac-loc adaptor.A visual examination discovered the flare to be concentric in shape.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The customer did not provide a lot number.Cook medical performed an expanded sales search for the reporting facility from 05jan2019 through 05jan2023.The search could not identify the complaint lot.As a result, a device history record could not be reviewed due to the lack of information.Cook reviewed the product labeling for the complaint device.The instructions for use (ifu) [ t_multi_rev5], multipurpose drainage catheter] states the following in relation to the reported failure mode.Precautions ¿ when inserting a stiffening cannula into a catheter with retention suture, hold suture during cannula insertion to avoid bunching or tangling of suture.-a tfe-coated wire guide must be used with ultrathane catheters.¿ patients with indwelling drainage catheters should be evaluated routinely to ensure continuous function of the catheter.Instructions for use: unlocking catheter loop for mac-loc locking loop mechanism: a.While stabilizing the mac-loc catheter hub assembly with one hand, position a small, blunt object (approximately the shape and size of a ball point pen or small forceps) into the mac-loc release notch.B.Pry upward until the locking cam lever is free.(fig.4) how supplied: "upon removal from package, inspect the product to ensure no damage has occurred." the information provided upon review of the dmr, ifu, and device evaluation suggests that the device was not manufactured out of specification, and that there are no nonconforming devices in house or out in the field.Based on the information provided, inspection of the returned device, and the results of the investigation, it was determined there is no evidence of manufacturing deficiency.The user did not identify any damage during initial placement.It is possible the device separated during patient transfer.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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.

• 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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 16156519
• MDR Text Key: 307263051
• Report Number: 1820334-2023-00027
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/16/2023

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 Catalogue Number: ULT14.0-38-25-P-6S-CLM-RH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2023
• Initial Date FDA Received: 01/13/2023
• Supplement Dates Manufacturer Received: 01/13/2023; 02/06/2023; 05/31/2023
• Supplement Dates FDA Received: 01/18/2023; 02/09/2023; 06/16/2023
• 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
• Patient Sex: Female