MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; DQX WIRE, GUIDE, CATHETER

Model Number N/A

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: tscf-35-80-3.Occupation: unknown.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 a ultrathane mac-loc locking loop multipurpose drainage catheter was used in an unknown patient for an unknown procedure.As reported, the guidewire became stuck in trocar, causing shearing of the guidewire as it was being removed.The report alleges the guidewire stretched and partially tore.Staff confirmed no fragmentation of the guidewire occurred.The guidewire involved in this complaint is reported under medwatch report # 1820334-2019-00733.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Additional information regarding the event and patient outcome has been requested but is currently unavailable.

Manufacturer Narrative

D10: product received on 16apr2019.Investigation/evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, and quality control of the device, as well as a visual inspection, dimensional verification, and functional test, were conducted during the investigation.One wire guide stuck within the needle cannula was returned for investigation.Physical inspection of the returned components showed the components were in a used condition.The wire guide was returned within the cannula.The proximal end of the wire guide was protruding from the hub of the cannula.It was removed from the cannula, with resistance, revealing it to be elongated and damaged.Elongation was primarily located at the middle portion of the wire guide, with the proximal and distal ends remaining intact.No damage was observed on the cannula.Dimensional analysis could not be performed on the wire guide due to its returned condition.The investigators attempted to recreate the failure mode using a representative 0.035" wire guide.It met resistance during insertion, and dislodged a hard piece of what appeared to be dried biomatter.After removal of the occlusion, the representative wire guide passed easily through the cannula.Based on the investigation, there is no evidence to suggest the components were not manufactured within the correct specifications additionally, a document based investigation evaluation was performed for lot 9276621 and revealed no related nonconformances to the reported failure mode.A review of the cannula/trocar needle subassembly lot also revealed no reported nonconformances.A software search at the time of investigation revealed no other complaints have been reported for the complaint lot.As there are no related nonconformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or out in the field.Based on the information provided, investigation of returned product, and the results of the investigation, cook concluded that events during the procedure likely contributed to the failure mode.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required 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

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

Manufacturer Narrative

The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.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 29mar2019.It was reported that during removal of the complaint device, resistance was encountered by the user as "the wire was being removed through the trocar included in the pigtail catheter kit." no kinking of the wire was noted during the procedure.It was also reported that the complaint device was placed in the "left lower quadrant (for) intra-abdominal fluid collection", which was accomplished "through an 18g introducer needle." the issue was noted during the procedure and the patient required "an abdominal x-ray to assess for wire fragments." the patient was "bed bound" and "the catheter was locked at the end of the procedure when it was attached up to the drainage bag.".

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Type of Device: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8449467
• MDR Text Key: 139755444
• Report Number: 1820334-2019-00734
• Device Sequence Number: 1
• Product Code: DXQ
• UDI-Device Identifier: 00827002095014
• UDI-Public: (01)00827002095014(17)211031(10)9276621
• 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: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-25-P-6S-CLM-RH
• Device Lot Number: 9276621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Date Manufacturer Received: 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1