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 Problems Material Separation (1562); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/02/2021

Event Type  malfunction  

Manufacturer Narrative

Customer (person): postal code: (b)(6).Occupation: charge tech.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.

Event Description

It was reported an unspecified 8.5fr multipurpose drainage catheter separated following removal from a female patient.Approximately three months after placement, on x-ray imaging, the device appeared separated.When the catheter was removed from the patient, it "ballooned up" and broke.The device was replaced with another drainage catheter.No other adverse effects were reported.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.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

In additional information, it was reported that the catheter was removed and replaced during a routine three month nephrostomy change.At this time a "bulb" was discovered on the catheter.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

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

Upon return of the device, it was confirmed to be an ultrathane mac-loc locking loop multipurpose drainage catheter.

Manufacturer Narrative

Investigation ¿ evaluation a complaint was received by cook medical on 02sep2021 from a representative at the (b)(6) hospital in (b)(6).When the ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter (rpn: ult8.5-38-25-p-6s-clm-rh) was in-place, it appeared on x-ray that the device ballooned-up and ruptured during a routine 3-month nephrostomy change.The catheter was removed from the patient and replaced with a new one.The patient did not experience any additional adverse effects due to this occurrence.Reviews of the documentation including the complaint history, device history record, drawing, instructions for use (ifu) and specifications, as well as a visual inspection of the returned device, were conducted during the investigation.One ult8.5-38-25-p-6s-clm-rh was returned for evaluation in a used and damaged condition.A visual examination confirmed ¿ballooning¿ of the shaft, measuring 10cm from the distal tip.No evidence of catheter rupture could be found.Dried biological matter was present on the catheter at the distal portion, distal tip and within the lumen.A further examination discovered that all five side ports were occluded with dried biological matter.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded sufficient inspection activities are in place to identify this failure mode prior to distribution.An expanded sales search was conducted for the reporting facility between 02sep2018 and 02sep2021, in which three possible lots with the product description of ult-8.5-38-25-p-6s-clm-rh, ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter were identified (13135101, 13345889 and 1391185).A review of the device history record (dhr) for lots 13911857 and subassembly lots sa10256679 and sa13256738 found relevant nonconformances for ¿tip/taper inadequate,¿ in which nonconforming devices were scrapped prior to further processing.Subassembly lot sa13742720 also had relevant recorded nonconformances for ¿i.D.Incorrect,¿ in which all devices were scrapped prior to further processing.It should be noted that there were no other complaints associated with the three identified final product lot numbers.As there is objective evidence that the dhr's were fully executed, and there were no other lot-related complaints that have been received from the field, cook has concluded that there is no evidence that nonconforming product exists in house, in the field and that device was manufactured to current specification.Cook also reviewed product labeling.The current instructions for use [ifu t_multi_rev 5] state the following: "precautions patients with indwelling drainage catheters should be evaluated routinely to ensure continuous function of the catheter." based on the information provided, examination of the returned product and the results of our investigation, it was concluded that a component failure without a design or manufacturing deficiency contributed to the reported event.The appropriate personnel have been notified.Per the risk assessment no further action is required.We 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 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

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

• 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: 12488876
• MDR Text Key: 271933095
• Report Number: 1820334-2021-02168
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/05/2022

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: ULT8.5-38-25-P-6S-CLM-RH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 09/17/2021
• Supplement Dates Manufacturer Received: 10/22/2021; 10/21/2021; 06/10/2022
• Supplement Dates FDA Received: 10/22/2021; 10/25/2021; 07/05/2022
• Was Device Evaluated by Manufacturer?: 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 Age: 59 YR
• Patient Sex: Female